Clinical Trials List
Protocol NumberA3921092
2013-12-03 - 2020-08-10
Phase III
Terminated4
Study ended1
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 LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
-
Sponsor
Pfizer
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- Yun-Ting Chang Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 梁培英 Division of Rheumatology
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
- Jiunn-Horng Chen 風濕免疫科
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
- 吳柏樟 風濕免疫科
- Chung-Ming Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
PSORIATIC ARTHRITIS
Objectives
To evaluate the long term safety and tolerability of treatment with tofacitinib (5 mg BID and 10 mg BID) in adult subjects with active Psoriatic Arthritis (PsA).
To evaluate the long term efficacy of tofacitinib (5 mg BID and 10 mg BID) in adult
subjects with active PsA.
Test Drug
XELJANZ XR
Active Ingredient
Tofacitinib (CP-690,550)
Dosage Form
tablet
Dosage
5
Endpoints
This is a Phase 3, long-term, open-label extension study designed to evaluate the safety,
tolerability and efficacy of tofacitinib in subjects with active PsA. Subjects with active PsA
will have previously participated in randomized studies of tofacitinib. For subjects who are
completing participation in a randomized study of tofacitinib, the final visit of the qualifying
study can be combined with screening and baseline visit for this study. Additional
assessments and inclusion/exclusion criteria are required for subjects who enroll >14 days
after completing treatment in their qualifying study. In this case, a separate screening visit to determine subject eligibility is required followed by a baseline visit.
All eligible subjects from qualifying studies A3921091 and A3921125 will receive
open-label tofacitinib 5 mg BID upon entry into A3921092. Subjects from A3921091 will
receive first dose of study medication 1 week after last injection of study medication in that qualifying study. Tofacitinib dose may be increased to 10 mg BID at study visits if, based upon investigator’s discretion, subjects receiving tofacitinib 5 mg BID would benefit from a higher dose and are not experiencing any tofacitinib-related adverse events, including abnormalities in laboratory test results that are judged to be related to tofacitinib. Tofacitinib dose may be decreased (ie, 10 mg BID to 5 mg BID) for safety reasons at any time.
Treatment duration for subjects participating in this study is 3 years.
At various time points in this trial, safety measurements, including physical examination,
clinical laboratory tests, adverse event monitoring, electrocardiograms (ECGs) and vital signs will be performed. All subjects will be monitored for clinical evidence of PsA response to treatment. Health Outcomes Measures (ie, Patient Reported Outcomes assessments for pain, quality of life, physical function, fatigue, work limitations, health care resource utilization and health status) will also be performed at various time points in this trial. In addition, subjects will be monitored for serious infections, lymphadenopathy and lymphoproliferative disorder (LPD).
tolerability and efficacy of tofacitinib in subjects with active PsA. Subjects with active PsA
will have previously participated in randomized studies of tofacitinib. For subjects who are
completing participation in a randomized study of tofacitinib, the final visit of the qualifying
study can be combined with screening and baseline visit for this study. Additional
assessments and inclusion/exclusion criteria are required for subjects who enroll >14 days
after completing treatment in their qualifying study. In this case, a separate screening visit to determine subject eligibility is required followed by a baseline visit.
All eligible subjects from qualifying studies A3921091 and A3921125 will receive
open-label tofacitinib 5 mg BID upon entry into A3921092. Subjects from A3921091 will
receive first dose of study medication 1 week after last injection of study medication in that qualifying study. Tofacitinib dose may be increased to 10 mg BID at study visits if, based upon investigator’s discretion, subjects receiving tofacitinib 5 mg BID would benefit from a higher dose and are not experiencing any tofacitinib-related adverse events, including abnormalities in laboratory test results that are judged to be related to tofacitinib. Tofacitinib dose may be decreased (ie, 10 mg BID to 5 mg BID) for safety reasons at any time.
Treatment duration for subjects participating in this study is 3 years.
At various time points in this trial, safety measurements, including physical examination,
clinical laboratory tests, adverse event monitoring, electrocardiograms (ECGs) and vital signs will be performed. All subjects will be monitored for clinical evidence of PsA response to treatment. Health Outcomes Measures (ie, Patient Reported Outcomes assessments for pain, quality of life, physical function, fatigue, work limitations, health care resource utilization and health status) will also be performed at various time points in this trial. In addition, subjects will be monitored for serious infections, lymphadenopathy and lymphoproliferative disorder (LPD).
Inclution Criteria
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. Subjects must have a diagnosis of PsA and previously completed participation in a
qualifying study of tofacitinib for the treatment of PsA or have required earlier
discontinuation of treatment in a qualifying study for reasons other than
treatment-related adverse events with the written approval of the Pfizer Clinician.
4. Subject must be at least 18 years of age (20 years old for subjects in Taiwan) or older
at the Screening visit.
5. Subjects receiving permitted traditional background DMARDs, eg, methotrexate,
sulfasalazine or leflunomide, must be dosed in accordance with the local regulatory
label.
All local standard of care practices for administration of background DMARD
therapy, including laboratory testing, contraceptive requirements, follow-up care and
contraindications, should be performed according to the local standards of care
throughout the study.
Methotrexate: Maximum dose of 20 mg/week. Minimum duration of therapy
4 months and dose stable for 4 weeks prior to first dose of study drug.
Subjects on methotrexate should be on an adequate and stable dose of folate
supplementation (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 study drug (see Section 5.5). Subjects must
not have had previous serious toxicity while on methotrexate and not be
expected to require evaluation for possible methotrexate toxicity (eg, require a
liver biopsy for methotrexate toxicity) during the study.
Sulfasalazine: Maximum dose of 3 gm/day. Minimum duration of therapy
2 months and dose stable for 4 weeks prior to first dose of study drug.
Leflunomide: Maximum dose of 20 mg/day. Minimum duration of therapy
4 months and dose stable for 4 weeks prior to first dose of study drug.
Other traditional DMARDs not listed as a prohibited concomitant medication
(see Appendix 3) may be considered after discussion with the Sponsor.
6. Subjects who are already taking oral corticosteroids (but not injectable) 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 first dose of study drug. Injected (eg, intraarticular, intramuscular or intravenous) corticosteroids: Discontinued 4 weeks prior to the first dose of study drug.
7. Subjects who are already taking NSAIDs/COX-2 inhibitors may participate in the
study provided that that the dose is stable for one week prior to first dose of study
drug.
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. Subjects must have a diagnosis of PsA and previously completed participation in a
qualifying study of tofacitinib for the treatment of PsA or have required earlier
discontinuation of treatment in a qualifying study for reasons other than
treatment-related adverse events with the written approval of the Pfizer Clinician.
4. Subject must be at least 18 years of age (20 years old for subjects in Taiwan) or older
at the Screening visit.
5. Subjects receiving permitted traditional background DMARDs, eg, methotrexate,
sulfasalazine or leflunomide, must be dosed in accordance with the local regulatory
label.
All local standard of care practices for administration of background DMARD
therapy, including laboratory testing, contraceptive requirements, follow-up care and
contraindications, should be performed according to the local standards of care
throughout the study.
Methotrexate: Maximum dose of 20 mg/week. Minimum duration of therapy
4 months and dose stable for 4 weeks prior to first dose of study drug.
Subjects on methotrexate should be on an adequate and stable dose of folate
supplementation (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 study drug (see Section 5.5). Subjects must
not have had previous serious toxicity while on methotrexate and not be
expected to require evaluation for possible methotrexate toxicity (eg, require a
liver biopsy for methotrexate toxicity) during the study.
Sulfasalazine: Maximum dose of 3 gm/day. Minimum duration of therapy
2 months and dose stable for 4 weeks prior to first dose of study drug.
Leflunomide: Maximum dose of 20 mg/day. Minimum duration of therapy
4 months and dose stable for 4 weeks prior to first dose of study drug.
Other traditional DMARDs not listed as a prohibited concomitant medication
(see Appendix 3) may be considered after discussion with the Sponsor.
6. Subjects who are already taking oral corticosteroids (but not injectable) 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 first dose of study drug. Injected (eg, intraarticular, intramuscular or intravenous) corticosteroids: Discontinued 4 weeks prior to the first dose of study drug.
7. Subjects who are already taking NSAIDs/COX-2 inhibitors may participate in the
study provided that that the dose is stable for one week prior to first dose of study
drug.
Exclusion Criteria
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. Pregnant females, breastfeeding females and females of child-bearing potential who
are unwilling or unable to use a highly effective method of contraception as outlined
in this protocol for the duration of the study and 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 4.4.6).
4. Current or recent history of uncontrolled renal, hepatic, hematological,
gastrointestinal, metabolic (including hypercholesterolemia), endocrine, pulmonary,
cardiovascular, or neurologic disease.
5. 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.
6. A subject with known immunodeficiency disorder or a first degree relative with a
hereditary immunodeficiency.
7. Functional Class IV status as defined by the American College of Rheumatology
classification of functional status for RA, ie, limited in ability to perform usual
self-care, vocational and avocational activities.18
8. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
9. 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.
10. History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.
11. 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.
12. 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 4.4.2 Vaccine Guidelines for further information
regarding avoidance of household contacts who may be vaccinated).
13. 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.
14. 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.
15. A subject requiring prohibited concomitant medications (See Appendix 3). Subjects
receiving non-prohibited concomitant medications must be on a stable regimen which
is defined as not starting a new drug or changing dosage within seven days or
5 half-lives (whichever is longer) prior to the baseline visit
16. A subject known to be infected with human immunodeficiency virus (HIV),
hepatitis B virus or hepatitis C virus or any chronic infection.
HBsAg+
is exclusionary; subjects who are HBsAgbut HBcAb+ must undergo
further testing and be HBsAb+ to be considered for enrollment.
Subjects who are HCV Ab+ must undergo further testing for HCV RNA and are allowed to enroll if negative.
17. 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.
18. 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.
19. A subject who, in the opinion of the investigator or Pfizer (or designee), will be
uncooperative or unable to comply with study procedures.
20. Participation in other studies involving investigational drug(s) (Phases 1-4) during
study participation.
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. Pregnant females, breastfeeding females and females of child-bearing potential who
are unwilling or unable to use a highly effective method of contraception as outlined
in this protocol for the duration of the study and 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 4.4.6).
4. Current or recent history of uncontrolled renal, hepatic, hematological,
gastrointestinal, metabolic (including hypercholesterolemia), endocrine, pulmonary,
cardiovascular, or neurologic disease.
5. 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.
6. A subject with known immunodeficiency disorder or a first degree relative with a
hereditary immunodeficiency.
7. Functional Class IV status as defined by the American College of Rheumatology
classification of functional status for RA, ie, limited in ability to perform usual
self-care, vocational and avocational activities.18
8. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
9. 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.
10. History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.
11. 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.
12. 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 4.4.2 Vaccine Guidelines for further information
regarding avoidance of household contacts who may be vaccinated).
13. 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.
14. 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.
15. A subject requiring prohibited concomitant medications (See Appendix 3). Subjects
receiving non-prohibited concomitant medications must be on a stable regimen which
is defined as not starting a new drug or changing dosage within seven days or
5 half-lives (whichever is longer) prior to the baseline visit
16. A subject known to be infected with human immunodeficiency virus (HIV),
hepatitis B virus or hepatitis C virus or any chronic infection.
HBsAg+
is exclusionary; subjects who are HBsAgbut HBcAb+ must undergo
further testing and be HBsAb+ to be considered for enrollment.
Subjects who are HCV Ab+ must undergo further testing for HCV RNA and are allowed to enroll if negative.
17. 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.
18. 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.
19. A subject who, in the opinion of the investigator or Pfizer (or designee), will be
uncooperative or unable to comply with study procedures.
20. Participation in other studies involving investigational drug(s) (Phases 1-4) during
study participation.
The Estimated Number of Participants
-
Taiwan
26 participants
-
Global
700 participants
