A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis
- Conditions
- Rheumatoid arthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2006-005035-19-FI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4500
Patients who enroll from a qualifying study within a 14 day window must meet Inclusion Criteria 1, 2, 4, 6, 7 and 8 below and must continue to meet safety eligibility criteria of their qualifying study for continued participation. Patients who enroll after the 14 day window must meet all Inclusion Criteria including Inclusion Criteria 3 and 5 to be eligible for enrollment into the trial. 1. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 2. Patient must be at least the legally recognized age of consent or provide assent in writing along with a consent signed by their legally recognized representative. 3. In the opinion of the investigator the patient must have sufficient evidence of RA disease activity to warrant use of CP-690,550 as a DMARD. 4. Patients must have previously completed participation in a qualifying study of CP 690,550 for treatment of RA or have required earlier discontinuation of treatment in a qualifying study for reasons other than CP 690,550 related serious adverse events with the approval of the Pfizer study clinician. 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®TM In-Tube test performed within the 3 months prior to screening. A negative PPD test can be substituted for the QuantiFERON TB Gold 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 Medical Monitor approves it, on a case-by-case basis; A chest radiograph taken within the 3 months prior to screening without changes suggestive of active TB infection; No history of either untreated or inadequately treated latent or active TB infection. If a patient has previously received an adequate course of therapy for either latent (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, neither a PPD test nor a QuantiFERON Gold®TM test need be obtained, but a chest radiograph must still be obtained if not done so within the prior 3 months. A patient who is currently being treated for latent 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. In Ireland, patients currently being treated for either latent or active TB infection cannot be enrolled. 6. The patient has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol. 7. If the patient is a sexually active woman of childbearing potential, she must test negative for pregnancy prior to enrollment in this study. Sexually active women of childbearing potential are required to use adequate contraceptive methods during participation in this study. Men who are on background therapy and whose partners are women of childbearing potential will be required to follow the local label requirements for their background medications (including background DMARDs). Further description of the requirements and a list
For patients who do not rollover into this study within 14 days of their last visit of qualifying study(1-5): 1.Evidence of hematopoietic disorders or evidence of hemoglobin levels or hematocrit as defined in protocol 2.An absolute WBC count of <3.0 x 10^9/L <3000/mm3), absolute neutrophil count of <1.2 x 10^9/L (<1200/mm3), or absolute lymphocyte count of <0.5 x 10^9/L (<500/mm3) at screening visit or within 3 months prior to baseline. For patients in Czech Republic, Denmark, Germany, Spain, Sweden, Ireland, and the UK, absolute lymphocyte count <0.75 x 10^9/L (<750/mm3) at screening visit or within 3 months prior to baseline. 3. Thrombocytopenia as defined in protocol. 4.Estimated creatinine clearance as defined in protocol. 5.Total bilirubin, AST or ALT more than 1.5 times ULN at screening visit. For all patients: 6.Pregnant or lactating women. 7.Current or recent history of uncontrolled clinically significant renal,hepatic,hematological, gastro-intestinal,endocrine,pulmonary,cardiac, or neurological disease. 8.History of any other rheumatic autoimmune disease other than Sjogren’s syndrome. 9.History of an infected joint prosthesis at any time,with the prosthesis still in situ.10.History of any lympho-proliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease. 11.History of recurrent (more than 1 episode) herpes zoster or disseminated(a single episode)herpes zoster or disseminated (a single episode)herpes simplex. 12.Patients with any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by investigator within the 6 mths prior to the first dose of study drug. 13.Any other condition which would make patient unsuitable for inclusion.14.Participation in studies of investigational compounds as defined in protocol. Exposure to investigational biologics should be discussed with Pfizer Medical Monitor. 15.Any prior treatment with non B cell-specific lymphocyte depleting agents / therapies. See protocol for rituximab. 16. Intramuscular or intravenous corticosteroids in 4 wks preceding baseline. If an intra-articular injection is performed in the course of a qualifying study <4 wks before baseline visit of this study, the injected joint will be considered to have its pre-injection status from the qualifying study for full length of this protocol. 17.Patients who have been vaccinated with live or attenuated vaccines within 6 weeks prior to the first dose of study drug or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study drug. 18.Patients with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy or certain types of bariatric surgery such as gastric bypass. Bariatric procedures such as gastric banding that simply divide stomach into separate chambers are NOT exclusionary. 19.History of alcohol or substance abuse, unless in full remission for >6 months prior to first dose of study drug. 20.Screening 12 lead electrocardiogram that demonstrates clinically relevant abnormalities that may affect patient safety. 21.Patients with a first degree relative with a hereditary immunodeficiency. 22. Patients 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method