A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS

• Register: EUCTR
• Last refreshed on: 20 April 2020
• Main ID: EUCTR2011-002169-39-PL
• Date of registration: 17/12/2013
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
• Scientific title: A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS Paediatric investigation plan numbers - (P/144/2010),(P/162/2011) and (P/0064/2012). - OPAL Balance
• Date of first enrolment: 21/01/2014
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002169-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Mexico, Poland, Russian Federation, Slovakia, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1. 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 (exception being injection-related AEs) with the written approval of the Pfizer Clinician.
2. Subject must be at least 18 years of age (20 years old for subjects in Taiwan) or older at the Screening visit.
3. Subjects receiving permitted traditional non-biologic 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 non-biologic 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 (Background DMARDs as per protocol).
• Other traditional non-biologic DMARDs not listed as a prohibited concomitant medication may be considered after discussion with the Sponsor.
4. 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.
5. 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.

Inclusion Criteria That Apply to Subjects Who Enroll Into This Study After the 14 Day Window From the End of Study Visit of the Qualifying Study
1. Time from End of Study visit of qualifying study must be =3 months.
2. In the opinion of the investigator, the subject must have sufficient evidence of PsA disease activity to warrant use of tofacitinib as a DMARD.
3. Subject has discontinued all disallowed concomitant medications for the required time prior to the first dose of study medication and is taking only those concomitant medications in doses and frequency allowed by the protocol. Subjects who are receiving any investigational or marketed treatment for PsA or psoriasis not mentioned elsewhere must have that treatment discontinued for 4 weeks or 5 half-lives, whichever is longer. Discontinuation criteria for biologics not otherwise mentioned must be discussed with the Pfizer Study Clinician.
4.Screening 12-lead electrocardiogram (ECG) that does not
demonstrate clinically relevant abnormalities which may affect subject
safety.
5.No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
• A negative QuantiFERON-Gold®
• In-Tube test performed within the 3 months prior to screening. A negative PPD test can be substituted for the QuantiFERON Gold (QFT-G) In-Tube test only if the central laboratory is unable to perform the test or cannot determine the results to be positive or negative and the Pfizer Study Clinician approves it, on a case by case basis. Subjects with a history of Bacille Calmette Guérin (BCG) vaccination will be tested with the QFT-G test.
• No local QFT-G testing will be accepted for meeting the inclusion criterion.
•
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.
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.
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. History of active infection (including localized 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 study medication;
• Requiring oral antimicrobial therapy within 2 weeks prior to the first
dose of study medication.
12. 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.
13. 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.
14. 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.
15. A

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriatic arthritis (PsA)
MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: Tofacitinib
Product Code: CP-690,550
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tofacitinib
CAS Number: 477600-75-2
Current Sponsor code: CP-690,550
Other descriptive name: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Methotrexate 2.5 mg tablets
Pharmaceutical Form: Capsule
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Primary Endpoints
• Incidence and severity of adverse events.
• Incidence of clinical abnormalities and change from baseline (in this and/or prior study) in clinical laboratory values during treatment.

Secondary Objective: • To evaluate the long term efficacy of treatment with tofacitinib (5 mg BID and 10 mg BID) in adult subjects with active Psoriatic Arthritis (PsA).

Timepoint(s) of evaluation of this end point: As above

Main Objective: • To evaluate the long term safety and tolerability of treatment with tofacitinib (5 mg twice daily [BID] and 10 mg BID) in adult subjects with active Psoriatic Arthritis (PsA).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: As above.

Secondary end point(s): Secondary Endpoints
• ACR20, ACR50 and ACR70 response rate at all timepoints.
• HAQ-DI score at all timepoints.
• Psoriatic Arthritis Response Criteria (PsARC) response at all timepoints.
• Physician’s Global Assessment of Psoriasis (PGA-PsO) response at all timepoints.
• Psoriasis Area and Severity Index 75 (PASI75) response ie, the proportion of subjects achieving at least a 75% reduction in PASI relative to baseline (in this and/or prior study) and PASI/PASI component scores at all time points.
• Dactylitis severity score at all timepoints.
• Enthesitis score (using Spondyloarthritis Research Consortium of Canada (SPARCC)
Enthesitis Index and Leed’s Index) at all time points.
• Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) at all timepoints.
• Physical function/other patient reported outcomes to be assessed at Month 1, Month 6 (and every 6 months thereafter): Short-Form 36 (version 2, Acute); EQ5D; FACIT-F.

Secondary ID(s)

2011-002169-39-BE

A3921092

Source(s) of Monetary Support

Pfizer Inc

Ethics review

Status: Approved
Approval date: 17/12/2013
Contact: