Clinical Trials List
Protocol NumberA3921120
NCT Number(ClinicalTrials.gov Identfier)無 NCT03502616
Completed
2018-06-30 - 2022-06-30
Phase III
Terminated4
ICD-10M47.9
Spondylosis, unspecified
ICD-10M45
Ankylosing spondylitis
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)
-
Sponsor
Pfizer
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 李盈萱 風濕免疫科
- 張詩欣 風濕免疫科
- 石硯如 風濕免疫科
- 洪偉哲 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Tzn-Min Lin 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
ACTIVE ANKYLOSING SPONDYLITIS (AS)
Objectives
Primary Objective:
To compare the efficacy of tofacitinib 5 mg BID
versus placebo on the ASAS20 response rate at Week
16 in subjects with active AS that have had an
inadequate response to previous treatment.
Secondary Objective:
To compare the safety and tolerability of tofacitinib 5 mg
BID versus placebo in subjects with active AS that have
had an inadequate response to previous treatment.
To compare the efficacy of tofacitinib 5 mg BID
versus placebo at all time points in subjects with
active AS that have had an inadequate response to
previous treatment.
To measure the effect of tofacitinib 5 mg BID on the
quality of life and functional well-being at all
collected time points.
Test Drug
Xeljanz
Active Ingredient
Tofacitinib
Dosage Form
tablet
Dosage
5mg
Endpoints
Primary Endpoint:
ASAS20 response at 16 weeks.
Secondary Endpoints:
Incidence and severity of Adverse Events (AE).
Clinical laboratory tests, vital signs, physical
examination and 12-lead ECG parameters.
ASAS40 response at all time points.
ASAS20 response at all other time points.
ASAS 5/6 response at all time points.
Ankylosing Spondylitis Disease Activity Score using
C-Reactive Protein (ASDASCRP) at all time points.
hsCRP.
ASDAS clinically important improvement, ASDAS
major improvement and ASDAS inactive disease at
all time points.
Bath Ankylosing Spondylitis Disease Activity Index
(BASDAI) at all time points.
BASDAI50 response at all time points.
Bath Ankylosing Spondylitis Functional Index
(BASFI) at all time points.
Bath Ankylosing Spondylitis Metrology Index
(BASMI) at all time points.
Maastricht Ankylosing Spondylitis Enthesitis Score
(MASES) at all time points collected.
Extra-articular Involvement (Specific Medical
History and peripheral articular involvement [as
assessed by swollen joint count]) at all time points
collected.
Spinal mobility at all time points collected.
ASAS partial remission criteria at all time points.
Short-Form-36 Health Survey (SF-36) Version 2,
Acute at all time points collected.
EuroQol EQ-5D Health State Profile (EQ-5D) and
Your own health state today (EQ-VAS), at all time
points collected.
Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT-F) at all time points.
Ankylosing Spondylitis Quality of Life (ASQoL) at
all time points collected.
Work Productivity and Activity Impairment (WPAI)
Questionnaire: Spondyloarthritis at all time points
collected.
AS HealthCare Resource Utilization Questionnaire
(AS-HCRU) at all time points collected.
ASAS20 response at 16 weeks.
Secondary Endpoints:
Incidence and severity of Adverse Events (AE).
Clinical laboratory tests, vital signs, physical
examination and 12-lead ECG parameters.
ASAS40 response at all time points.
ASAS20 response at all other time points.
ASAS 5/6 response at all time points.
Ankylosing Spondylitis Disease Activity Score using
C-Reactive Protein (ASDASCRP) at all time points.
hsCRP.
ASDAS clinically important improvement, ASDAS
major improvement and ASDAS inactive disease at
all time points.
Bath Ankylosing Spondylitis Disease Activity Index
(BASDAI) at all time points.
BASDAI50 response at all time points.
Bath Ankylosing Spondylitis Functional Index
(BASFI) at all time points.
Bath Ankylosing Spondylitis Metrology Index
(BASMI) at all time points.
Maastricht Ankylosing Spondylitis Enthesitis Score
(MASES) at all time points collected.
Extra-articular Involvement (Specific Medical
History and peripheral articular involvement [as
assessed by swollen joint count]) at all time points
collected.
Spinal mobility at all time points collected.
ASAS partial remission criteria at all time points.
Short-Form-36 Health Survey (SF-36) Version 2,
Acute at all time points collected.
EuroQol EQ-5D Health State Profile (EQ-5D) and
Your own health state today (EQ-VAS), at all time
points collected.
Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT-F) at all time points.
Ankylosing Spondylitis Quality of Life (ASQoL) at
all time points collected.
Work Productivity and Activity Impairment (WPAI)
Questionnaire: Spondyloarthritis at all time points
collected.
AS HealthCare Resource Utilization Questionnaire
(AS-HCRU) at all time points collected.
Inclution Criteria
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Subject is at least 18 years old (20 years old for subjects in Taiwan) at the screening visit.
4. The subject has a diagnosis of AS based on the Modified New York Criteria for Ankylosing Spondylitis (1984).
5. The subject must have a radiograph of the SI joints (AP Pelvis) documenting diagnosis of AS. Previous radiographs (up to 2 years old) can be used if they are accepted by the central reader. Otherwise, a new radiograph will be obtained at the Screening visit.
6. Subject has active AS Screening and Baseline (Day 1) visits defined as:
BASDAI score of ≥4; and
Back pain score (BASDAI Question 2) of ≥4.
7. Subject has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or is intolerant to NSAIDs as defined by:
Subject must have had at least a total of 2 occurrences of an inadequate clinical response (minimum or 4 week trial) or intolerance to at least 2 different oral NSAIDs. Intolerance is defined as having discontinued NSAID treatment due to a related adverse event (eg, allergic reaction, gastrointestinal symptoms or signs, hypertension, etc).
8. Subjects who are designated as TNFi-IR must have received at least 1, but not more than 2 approved TNF inhibiting biologic agent that was administered in accordance with its labeling recommendations and was inadequately effective after the minimum treatment times listed below and/or not tolerated after one or more doses.
• At least 3 months of adalimumab treatment;
• At least 3 months of etanercept treatment;
• At least 4 infusions of infliximab;
• At least 3 injections of golimumab;
• At least 3 months of certolizumab treatment.
Intolerance is defined as having experienced a treatment-related AE (eg, infusion/injection reactions, infections, laboratory test changes, etc).
9. Subjects may be receiving the following csDMARDs at the time of the screening visit. These medications should be continued throughout the entire study and doses should remain unchanged. Any other DMARDs require discussion prior to enrollment with the sponsor for washout timeframe.
•
Methotrexate (MTX): Maximum dose of 20 mg/week. Minimum duration of therapy 4 months and dose stable for 4 weeks prior to first dose of investigational product. Subjects on MTX should be on an adequate and stable dose of folate supplementation per local standards/regulatory approval (eg, not less than 5 mg weekly based on folic acid, unless such doses would violate the local label guidelines or standard of care) for at least 4 weeks prior to the first dose of investigational product. Subject must not have had previous serious toxicity while on MTX and not be expected to require evaluation for possible methotrexate toxicity (eg, require a liver biopsy for methotrexate toxicity) during the study;
• Sulfasalazine (Azulfidine®, Salazpyrin®): Maximum dose of 3 gm/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to first dose of investigational product.
10. Subjects who are already taking oral corticosteroids (not injectables) may participate in the study:
• Oral corticosteroids: Subjects who are already receiving oral corticosteroids must be on a stable dose of ≤10 mg/day of prednisone or equivalent for 4 weeks prior to the first dose of investigational product;
• Injected (eg, intraarticular, intramuscular, epidural or intravenous) corticosteroids must be discontinued 4 weeks prior to the first dose of investigational product;
• Topical and intra-rectal corticosteroids will be allowed during the study.
11. Subject has discontinued all disallowed concomitant medication for the required time prior to the first dose of investigational product.
12. Subjects who are receiving any investigational or marketed treatment for AS, arthritis or back pain not mentioned elsewhere must have that treatment discontinued for 4 weeks or 5 half-lives, whichever is longer.
13. Subjects receiving non-prohibited concomitant medications for any reason must be willing to stay on a stable regimen (doses and frequency) as defined in the protocol.
14. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
• A negative QuantiFERON®-TB Gold (QFT G) In Tube test performed at or within 3 months prior to the Screening visit. Subjects with a history of Bacille Calmette Guérin (BCG) vaccination will be tested with the QFT G test;
• No local QTF G testing will be accepted for meeting this inclusion criterion;
• A chest radiograph taken at or within the 3 months prior to screening and reviewed by a radiologist or pulmonologist as per local standard of care and documented to be without changes of suggestive active TB infection;
• No history of either untreated or inadequately treated latent or active TB infection.
NOTE: If a subject has previously received an adequate course of therapy for either latent (eg, 9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, a QuantiFERON®-TB Gold In Tube (QFT Gold test) need not be obtained, but a chest radiograph must still be obtained if not done so within the prior 3 months. A subject who is currently being treated for either latent or active TB infection can only be enrolled with confirmation of current incidence rates of multi drug resistant TB infection, documentation of an adequate treatment regimen, and prior approval of the Sponsor.
15. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
16. Female subjects of non-childbearing potential must meet at least 1 of the following criteria: • Achieved post-menopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with/and have a central laboratory confirmation of serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Subject is at least 18 years old (20 years old for subjects in Taiwan) at the screening visit.
4. The subject has a diagnosis of AS based on the Modified New York Criteria for Ankylosing Spondylitis (1984).
5. The subject must have a radiograph of the SI joints (AP Pelvis) documenting diagnosis of AS. Previous radiographs (up to 2 years old) can be used if they are accepted by the central reader. Otherwise, a new radiograph will be obtained at the Screening visit.
6. Subject has active AS Screening and Baseline (Day 1) visits defined as:
BASDAI score of ≥4; and
Back pain score (BASDAI Question 2) of ≥4.
7. Subject has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or is intolerant to NSAIDs as defined by:
Subject must have had at least a total of 2 occurrences of an inadequate clinical response (minimum or 4 week trial) or intolerance to at least 2 different oral NSAIDs. Intolerance is defined as having discontinued NSAID treatment due to a related adverse event (eg, allergic reaction, gastrointestinal symptoms or signs, hypertension, etc).
8. Subjects who are designated as TNFi-IR must have received at least 1, but not more than 2 approved TNF inhibiting biologic agent that was administered in accordance with its labeling recommendations and was inadequately effective after the minimum treatment times listed below and/or not tolerated after one or more doses.
• At least 3 months of adalimumab treatment;
• At least 3 months of etanercept treatment;
• At least 4 infusions of infliximab;
• At least 3 injections of golimumab;
• At least 3 months of certolizumab treatment.
Intolerance is defined as having experienced a treatment-related AE (eg, infusion/injection reactions, infections, laboratory test changes, etc).
9. Subjects may be receiving the following csDMARDs at the time of the screening visit. These medications should be continued throughout the entire study and doses should remain unchanged. Any other DMARDs require discussion prior to enrollment with the sponsor for washout timeframe.
•
Methotrexate (MTX): Maximum dose of 20 mg/week. Minimum duration of therapy 4 months and dose stable for 4 weeks prior to first dose of investigational product. Subjects on MTX should be on an adequate and stable dose of folate supplementation per local standards/regulatory approval (eg, not less than 5 mg weekly based on folic acid, unless such doses would violate the local label guidelines or standard of care) for at least 4 weeks prior to the first dose of investigational product. Subject must not have had previous serious toxicity while on MTX and not be expected to require evaluation for possible methotrexate toxicity (eg, require a liver biopsy for methotrexate toxicity) during the study;
• Sulfasalazine (Azulfidine®, Salazpyrin®): Maximum dose of 3 gm/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to first dose of investigational product.
10. Subjects who are already taking oral corticosteroids (not injectables) may participate in the study:
• Oral corticosteroids: Subjects who are already receiving oral corticosteroids must be on a stable dose of ≤10 mg/day of prednisone or equivalent for 4 weeks prior to the first dose of investigational product;
• Injected (eg, intraarticular, intramuscular, epidural or intravenous) corticosteroids must be discontinued 4 weeks prior to the first dose of investigational product;
• Topical and intra-rectal corticosteroids will be allowed during the study.
11. Subject has discontinued all disallowed concomitant medication for the required time prior to the first dose of investigational product.
12. Subjects who are receiving any investigational or marketed treatment for AS, arthritis or back pain not mentioned elsewhere must have that treatment discontinued for 4 weeks or 5 half-lives, whichever is longer.
13. Subjects receiving non-prohibited concomitant medications for any reason must be willing to stay on a stable regimen (doses and frequency) as defined in the protocol.
14. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
• A negative QuantiFERON®-TB Gold (QFT G) In Tube test performed at or within 3 months prior to the Screening visit. Subjects with a history of Bacille Calmette Guérin (BCG) vaccination will be tested with the QFT G test;
• No local QTF G testing will be accepted for meeting this inclusion criterion;
• A chest radiograph taken at or within the 3 months prior to screening and reviewed by a radiologist or pulmonologist as per local standard of care and documented to be without changes of suggestive active TB infection;
• No history of either untreated or inadequately treated latent or active TB infection.
NOTE: If a subject has previously received an adequate course of therapy for either latent (eg, 9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, a QuantiFERON®-TB Gold In Tube (QFT Gold test) need not be obtained, but a chest radiograph must still be obtained if not done so within the prior 3 months. A subject who is currently being treated for either latent or active TB infection can only be enrolled with confirmation of current incidence rates of multi drug resistant TB infection, documentation of an adequate treatment regimen, and prior approval of the Sponsor.
15. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
16. Female subjects of non-childbearing potential must meet at least 1 of the following criteria: • Achieved post-menopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with/and have a central laboratory confirmation of serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
Exclusion Criteria
1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
2. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation (excluding noninterventional follow-up during the screening period).
3. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
4. History of known or suspected complete ankylosis of the spine. This can be determined/confirmed at the time of the SI radiograph by the central reader.
5. Subjects receiving any other conventional synthetic or biological DMARDs (other than those allowed), thalidomide (including previous use) and other prohibited concomitant medications
6. Subjects that have been exposed to biological DMARDs other than TNF inhibitors.
7. Blood dyscrasias at screening or within 3 months prior to the first dose of investigational product including confirmed:
• Hemoglobin <10 g/dL;
• Absolute white blood cell count (WBC) <3.0 x 109/L (<3000 mm3);
• Absolute neutrophil count (ANC) <1.5 x 109/L (<1500 mm3);
• Absolute lymphocyte count <1.0 x 109/L (<1000/mm3);
• Platelet count <100 x 109/L (<100,000/mm3).
8. Estimated Creatinine Clearance <40 mL/min based on Cockcroft Gault equation at Screening visit.
9. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal (ULN) at screening visit.
One re-testing of a laboratory-acceptable specimen (eg, appropriately labeled, within stability parameters, not hemolyzed, appropriate type (tube and reagent) and volume) is allowed of any above parameters if the abnormal lab(s) was an uncharacteristic result(s). Documentation in the source of the typical results to allow a repeat lab is required.
Re-test must be completed within the screening period.
10. History of any other autoimmune rheumatic disease.
11. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
12. History of any lymphoproliferative disorder, such as Epstein Barr Virus related lymphoproliferative disease (EBV-LPD), history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
13. History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
14. History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 3 months prior to the first dose of investigational product.
15. History of infection requiring antimicrobial therapy within 2 weeks prior to the first dose of investigational product.
16. Any prior treatment with non-B cell specific lymphocyte depleting agents/therapies (eg, alemtuzamab, efalizumab), alkylating agents (eg, cyclophosphamide or chlorambucil), or total lymphoid irradiation.
17. Any subject who has been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of investigational product or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks after last dose of investigational product.
18. A subject with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding, that simply divide the stomach into separate chambers, are NOT exclusionary.
19. A subject that is considered at risk for GI perforation by the investigator or Sponsor.
20. History of alcohol or drug abuse unless in full remission for greater than 6 months prior to first dose of investigational product. Subjects currently using marijuana.
21. Screening 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities which may affect subject safety (eg, pattern of acute myocardial infarction, acute ischemia or serious arrhythmia) or interpretation of study results (eg, continuously paced ventricular rhythm or complete left bundle branch block).
22. A subject with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
23. A subject with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
24. Significant trauma or surgery procedure within 1 month prior to first dose of study medication, or any planned elective surgery during the study period.
25. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus or any chronic infection.
• Hepatitis B Surface Antigen positive (HBsAg+) is exclusionary; subjects who are HBsAg- but Hepatitis B core antibody positive (HBcAb+) must undergo further testing for HBsAb to be considered for enrollment. If HBsAb+, subject may enroll; if HBsAb-, subject is excluded.
• Subjects who are Hepatitis C Virus Antibody Positive (HCV Ab+) must undergo further testing for Hepatitis C Virus Ribonucleic Acid (HCV RNA). Subjects who are HCV RNA- may enroll.
26. A subject who has previously participated in any study of tofacitinib.
27. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential, who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
28. A subject who, in the opinion of the investigator or Pfizer (or designee), will be uncooperative or unable to comply with study procedures.
2. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation (excluding noninterventional follow-up during the screening period).
3. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
4. History of known or suspected complete ankylosis of the spine. This can be determined/confirmed at the time of the SI radiograph by the central reader.
5. Subjects receiving any other conventional synthetic or biological DMARDs (other than those allowed), thalidomide (including previous use) and other prohibited concomitant medications
6. Subjects that have been exposed to biological DMARDs other than TNF inhibitors.
7. Blood dyscrasias at screening or within 3 months prior to the first dose of investigational product including confirmed:
• Hemoglobin <10 g/dL;
• Absolute white blood cell count (WBC) <3.0 x 109/L (<3000 mm3);
• Absolute neutrophil count (ANC) <1.5 x 109/L (<1500 mm3);
• Absolute lymphocyte count <1.0 x 109/L (<1000/mm3);
• Platelet count <100 x 109/L (<100,000/mm3).
8. Estimated Creatinine Clearance <40 mL/min based on Cockcroft Gault equation at Screening visit.
9. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal (ULN) at screening visit.
One re-testing of a laboratory-acceptable specimen (eg, appropriately labeled, within stability parameters, not hemolyzed, appropriate type (tube and reagent) and volume) is allowed of any above parameters if the abnormal lab(s) was an uncharacteristic result(s). Documentation in the source of the typical results to allow a repeat lab is required.
Re-test must be completed within the screening period.
10. History of any other autoimmune rheumatic disease.
11. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
12. History of any lymphoproliferative disorder, such as Epstein Barr Virus related lymphoproliferative disease (EBV-LPD), history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
13. History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
14. History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 3 months prior to the first dose of investigational product.
15. History of infection requiring antimicrobial therapy within 2 weeks prior to the first dose of investigational product.
16. Any prior treatment with non-B cell specific lymphocyte depleting agents/therapies (eg, alemtuzamab, efalizumab), alkylating agents (eg, cyclophosphamide or chlorambucil), or total lymphoid irradiation.
17. Any subject who has been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of investigational product or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks after last dose of investigational product.
18. A subject with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding, that simply divide the stomach into separate chambers, are NOT exclusionary.
19. A subject that is considered at risk for GI perforation by the investigator or Sponsor.
20. History of alcohol or drug abuse unless in full remission for greater than 6 months prior to first dose of investigational product. Subjects currently using marijuana.
21. Screening 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities which may affect subject safety (eg, pattern of acute myocardial infarction, acute ischemia or serious arrhythmia) or interpretation of study results (eg, continuously paced ventricular rhythm or complete left bundle branch block).
22. A subject with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
23. A subject with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
24. Significant trauma or surgery procedure within 1 month prior to first dose of study medication, or any planned elective surgery during the study period.
25. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus or any chronic infection.
• Hepatitis B Surface Antigen positive (HBsAg+) is exclusionary; subjects who are HBsAg- but Hepatitis B core antibody positive (HBcAb+) must undergo further testing for HBsAb to be considered for enrollment. If HBsAb+, subject may enroll; if HBsAb-, subject is excluded.
• Subjects who are Hepatitis C Virus Antibody Positive (HCV Ab+) must undergo further testing for Hepatitis C Virus Ribonucleic Acid (HCV RNA). Subjects who are HCV RNA- may enroll.
26. A subject who has previously participated in any study of tofacitinib.
27. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential, who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
28. A subject who, in the opinion of the investigator or Pfizer (or designee), will be uncooperative or unable to comply with study procedures.
The Estimated Number of Participants
-
Taiwan
33 participants
-
Global
240 participants
