Clinical Trials List
Protocol NumberA39211125
2013-11-06 - 2017-07-31
Phase III
Terminated5
ICD-10L40.50
Arthropathic psoriasis, unspecified
ICD-10L40.51
Distal interphalangeal psoriatic arthropathy
ICD-10L40.52
Psoriatic arthritis mutilans
ICD-10L40.53
Psoriatic spondylitis
ICD-10L40.54
Psoriatic juvenile arthropathy
ICD-10L40.59
Other psoriatic arthropathy
ICD-9696.0
Psoriatic arthropathy
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE TNF INHIBITOR
-
Sponsor
Pfizer
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/19
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林尚宏 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yun-Ting Chang Division of Rheumatology
- Chien-Chih Lai Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jiunn-Horng Chen 風濕免疫科
- Chung-Ming Huang 風濕免疫科
- 吳柏樟 風濕免疫科
- 黃建中 風濕免疫科
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
1 Terminated
Condition/Disease
PSORIATIC ARTHRITIS
Objectives
1. To compare efficacy of tofacitinib at doses of 5 mg BID and 10 mg BID versus
placebo for treatment of rheumatological signs and symptoms of active PsA in
subjects who have had an inadequate response in PsA to at least one TNF
inhibitor.
2. To compare physical function status after administration of tofacitinib at doses of
5 mg BID and 10 mg BID versus placebo in subjects with active PsA who have had
an inadequate response in PsA to at least one TNF inhibitor.
3. To compare the safety and tolerability of tofacitinib at doses of 5 mg BID and 10 mg
BID versus placebo in subjects with active PsA who have had an inadequate response
in PsA to at least one TNF inhibitor.
Test Drug
Xeljanz
Active Ingredient
Tofacitinib（CP-690,550）
Dosage Form
tablet
Dosage
5
Endpoints
Primary study endpoints of ACR20 responder rate and HAQ-DI will be obtained at Month 3.
All subjects randomized to placebo will receive tofacitinib (5 or 10 mg BID in Treatment
Sequences C and D, respectively) after Month 3 in a blinded manner. During the study,
subjects should remain on a stable dose of one traditional DMARD, eg methotrexate,
sulfasalazine or leflunomide. At the end of Month 6, eligible subjects may enroll into the
open-label, long-term extension study A3921092.
All subjects randomized to placebo will receive tofacitinib (5 or 10 mg BID in Treatment
Sequences C and D, respectively) after Month 3 in a blinded manner. During the study,
subjects should remain on a stable dose of one traditional DMARD, eg methotrexate,
sulfasalazine or leflunomide. At the end of Month 6, eligible subjects may enroll into the
open-label, long-term extension study A3921092.
Inclution Criteria
Subject eligibility will be reviewed and documented by an appropriately qualified member of
the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
study:
1. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legal representative) has been informed of all pertinent aspects of the
study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
3. The subject has a diagnosis of PsA based upon the CASPAR Criteria for at least
6 months and evidence of active arthritis based upon number of tender/painful and
swollen joints detailed in Section 4.1.1. (below).
4. Ongoing treatment with a stable dose of a traditional DMARD (eg, methotrexate,
sulfasalazine or leflunomide) (Section 4.1.2 below).
5. Meet all other eligibility criteria described in Sections 4.2 and 4.3 below.
the investigator’s study team before subjects are included in the study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
study:
1. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legal representative) has been informed of all pertinent aspects of the
study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
3. The subject has a diagnosis of PsA based upon the CASPAR Criteria for at least
6 months and evidence of active arthritis based upon number of tender/painful and
swollen joints detailed in Section 4.1.1. (below).
4. Ongoing treatment with a stable dose of a traditional DMARD (eg, methotrexate,
sulfasalazine or leflunomide) (Section 4.1.2 below).
5. Meet all other eligibility criteria described in Sections 4.2 and 4.3 below.
Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
1. Currently have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular,
with the exception of nail psoriasis, which is allowed.
2. Subjects who are investigational site staff members directly involved in the conduct
of the trial and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the trial.
3. Participation in other interventional studies within 4 weeks before the current study
begins and/or during study participation. Participation in any observational studies
during study participation.
4. Pregnant females, breastfeeding females, females of child-bearing potential who are
not using highly effective contraception or not agreeing to continue highly effective
contraception for at least one ovulatory cycle after last dose of investigational product
or females planning pregnancy. Women of childbearing potential must test negative
for pregnancy prior to enrollment in this study. (Further description of the
requirements and a list of contraceptives considered highly effective and acceptable
for use in this study will be found in Section 4.6.6).
5. Blood dyscrasias within 3 months prior to the first dose of study drug including
confirmed:
a. Hemoglobin <10 g/dL (<100 g/L);
b. White blood cell count <3.0 x 109(<3000 mm3);
c. Absolute neutrophil count ≤1.5 x 109(<1500 mm3);
d. Absolute lymphocyte count of <1.0 x 109(<1000/mm3);
e. Platelet count <100 x 109(<100,000/mm3).
6. Estimated Creatinine Clearance <40 ml/min based on Cockcroft-Gault equation
(Appendix 2).
7. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at
screening visit.
8. Current or recent history of uncontrolled renal, hepatic, hematological,
gastrointestinal, metabolic (including hypercholesterolemia), endocrine, pulmonary,
cardiovascular, or neurologic disease.
9. History of any autoimmune rheumatic disease other than PsA (including systemic
lupus erythematosis, mixed connective tissue disease, scleroderma, polymyositis) or
known diagnosis of fibromyalgia, without approval by Sponsor. Also excluded are
subjects with prior history of, or current, rheumatic inflammatory disease other than
PsA (eg, gout, reactive arthritis, chronic Lyme disease) without approval by Sponsor.
10. A subject with known immunodeficiency disorder or a first degree relative with a
hereditary immunodeficiency.
11. Functional Class IV as defined by the American College of Rheumatology
classification of functional status for RA, ie limited in ability to perform usual selfcare, vocational and avocational activities.
12. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
13. History of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV)
related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and
symptoms suggestive of current lymphatic disease.
14. History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.
15. History of infection: Requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study medication; Requiring oral antimicrobial therapy within 2 weeks prior to the first dose of study medication.
16. Any prior treatment with non-B cell-specific lymphocyte depleting agents/therapies
[eg, alemtuzumab (Campath®), efalizumab (Raptiva®)], alkylating agents (eg, cyclophosphamide or chlorambucil), or total lymphoid irradiation. Subjects who have received rituximab or other selective B-lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least
1 year prior to first dose of study drug and have normal CD19/20+ counts by FACS
analysis.
17. Any subject who has been vaccinated with live or attenuated vaccines within the
6 weeks prior to the first dose of study medication or is to be vaccinated with these
vaccines at any time during treatment or within 6 weeks following discontinuation of
study medication. (See Section 4.6.2. Vaccine Guidelines for further information
regarding avoidance of household contacts who may be vaccinated).
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. History of alcohol or drug abuse unless in full remission for greater than 6 months
prior to first dose of study medication.
20. 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).
21. 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.
22. Significant trauma or surgery procedure within 1 month prior to first dose of study
medication, or any planned elective surgery during the study period.
23. A subject requiring prohibited concomitant medications (See Appendix 3).
24. A subject known to be infected with human immunodeficiency virus (HIV),
hepatitis B virus or hepatitis C virus or any chronic infection.
25. HBsAg+is exclusionary; subjects who are HBsAgbut HBcAb+ must undergo further
testing and be HBsAb+to be considered for enrollment.
26. Subjects who are HCVAb+ must undergo further testing for HCV RNA and are
allowed to enroll if negative.
27. A subject with evidence of skin conditions (eg, eczema) at the time of the screening
or baseline visit that would interfere with evaluation of psoriasis.
28. Other severe acute or chronic medical or psychiatric condition 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 judgement of investigator, would make subject inappropriate for
entry into this study.
29. A subject who has previously participated in any study of tofacitinib.
30. A subject who, in the opinion of the investigator or Pfizer (or designee), will be
uncooperative or unable to comply with study procedures.
1. Currently have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular,
with the exception of nail psoriasis, which is allowed.
2. Subjects who are investigational site staff members directly involved in the conduct
of the trial and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the trial.
3. Participation in other interventional studies within 4 weeks before the current study
begins and/or during study participation. Participation in any observational studies
during study participation.
4. Pregnant females, breastfeeding females, females of child-bearing potential who are
not using highly effective contraception or not agreeing to continue highly effective
contraception for at least one ovulatory cycle after last dose of investigational product
or females planning pregnancy. Women of childbearing potential must test negative
for pregnancy prior to enrollment in this study. (Further description of the
requirements and a list of contraceptives considered highly effective and acceptable
for use in this study will be found in Section 4.6.6).
5. Blood dyscrasias within 3 months prior to the first dose of study drug including
confirmed:
a. Hemoglobin <10 g/dL (<100 g/L);
b. White blood cell count <3.0 x 109(<3000 mm3);
c. Absolute neutrophil count ≤1.5 x 109(<1500 mm3);
d. Absolute lymphocyte count of <1.0 x 109(<1000/mm3);
e. Platelet count <100 x 109(<100,000/mm3).
6. Estimated Creatinine Clearance <40 ml/min based on Cockcroft-Gault equation
(Appendix 2).
7. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at
screening visit.
8. Current or recent history of uncontrolled renal, hepatic, hematological,
gastrointestinal, metabolic (including hypercholesterolemia), endocrine, pulmonary,
cardiovascular, or neurologic disease.
9. History of any autoimmune rheumatic disease other than PsA (including systemic
lupus erythematosis, mixed connective tissue disease, scleroderma, polymyositis) or
known diagnosis of fibromyalgia, without approval by Sponsor. Also excluded are
subjects with prior history of, or current, rheumatic inflammatory disease other than
PsA (eg, gout, reactive arthritis, chronic Lyme disease) without approval by Sponsor.
10. A subject with known immunodeficiency disorder or a first degree relative with a
hereditary immunodeficiency.
11. Functional Class IV as defined by the American College of Rheumatology
classification of functional status for RA, ie limited in ability to perform usual selfcare, vocational and avocational activities.
12. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
13. History of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV)
related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and
symptoms suggestive of current lymphatic disease.
14. History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.
15. History of infection: Requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study medication; Requiring oral antimicrobial therapy within 2 weeks prior to the first dose of study medication.
16. Any prior treatment with non-B cell-specific lymphocyte depleting agents/therapies
[eg, alemtuzumab (Campath®), efalizumab (Raptiva®)], alkylating agents (eg, cyclophosphamide or chlorambucil), or total lymphoid irradiation. Subjects who have received rituximab or other selective B-lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least
1 year prior to first dose of study drug and have normal CD19/20+ counts by FACS
analysis.
17. Any subject who has been vaccinated with live or attenuated vaccines within the
6 weeks prior to the first dose of study medication or is to be vaccinated with these
vaccines at any time during treatment or within 6 weeks following discontinuation of
study medication. (See Section 4.6.2. Vaccine Guidelines for further information
regarding avoidance of household contacts who may be vaccinated).
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. History of alcohol or drug abuse unless in full remission for greater than 6 months
prior to first dose of study medication.
20. 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).
21. 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.
22. Significant trauma or surgery procedure within 1 month prior to first dose of study
medication, or any planned elective surgery during the study period.
23. A subject requiring prohibited concomitant medications (See Appendix 3).
24. A subject known to be infected with human immunodeficiency virus (HIV),
hepatitis B virus or hepatitis C virus or any chronic infection.
25. HBsAg+is exclusionary; subjects who are HBsAgbut HBcAb+ must undergo further
testing and be HBsAb+to be considered for enrollment.
26. Subjects who are HCVAb+ must undergo further testing for HCV RNA and are
allowed to enroll if negative.
27. A subject with evidence of skin conditions (eg, eczema) at the time of the screening
or baseline visit that would interfere with evaluation of psoriasis.
28. Other severe acute or chronic medical or psychiatric condition 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 judgement of investigator, would make subject inappropriate for
entry into this study.
29. A subject who has previously participated in any study of tofacitinib.
30. 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
17 participants
-
Global
558 participants
