A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS - ND

• Register: EUCTR
• Last refreshed on: 31 January 2017
• Main ID: EUCTR2006-005035-19-IT
• Date of registration: 04/07/2007
• Prospective Registration: No
• Primary sponsor: PFIZER
• Public title: A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS - ND
• Scientific title: A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS - ND
• Date of first enrolment: 01/06/2007
• Target sample size: 550
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005035-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Slovakia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Ability to provide 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 trial. 2. Subject must be at least 18 years of age at the time of consent. 3. Subjects must either have previously completed study A3921019 or withdrawn from that study due to a. lack of efficacy if assigned to placebo arm OR b. unrelated AE or unrelated SAE with permission if assigned to 5 mg BID group OR c. any AE/SAE, if assigned to the 15 or 30 mg BID arms, except that subjects with treatment related SAE in A3921019 must obtain permission from sponsor to participate in A3921024. Such subjects are eligible for participation in A3921024 until 3 months after the initiation date of their original A3921019 study site for A3921024. If that site is not planned to participate in A3921024, then the nearest geographic site within the subject s country will be considered for these purposes. 4. Subjects must have previously completed at least 12 weeks participation in any other randomized qualifying study of CP-690,550 for the treatment of RA as long as not withdrawn due to treatment related AE or SAE. Subjects withdrawn due to unrelated AE or SAE must obtain sponsor permission before participating in this study. If subjects cannot combine the end of study visit for the previous CP-690,550 study with the screening/baseline visit for A3921024, they will be allowed a 7 day window in which to enroll into A3921024. 5. No alternative diagnosis of primary arthritic condition other than RA since time of completion of the qualifying study 6. For a subject who was previously in study A3921019, he/she must show evidence of continued active rheumatoid arthritis, defined as at least 6 swollen and 6 tender joints Continued Disease Activity Assessment Section 7.1.1 and elevation of either C reactive protein CRP or erythrocyte sedimentation rate ESR above the upper limit of normal of the reference laboratory at screening. 7. The patient has discontinued disallowed DMARD or immunosuppressive/immunomodulatory therapies prior to first dose of study medication, as defined in Appendix C. 8. If the subject is a sexually active woman of childbearing potential, she and any male partner must be willing to agree to contraceptive practices as detailed in the Lifestyle Guidelines of the protocol. 9. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception such as an IUD, barrier method with spermicide, oral contraceptive, injectable progesterone, sub dermal implant, or a tubal ligation, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures. 10. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
For Subjects who participated in A3921019 1-5 1. Evidence of hematopoietic disorders or evidence of hemoglobin levels 9 gm/dL or hematocrit 30 at screening visit or within the 3 months prior to baseline visit. 2. An absolute white blood cell WBC count of 3.0 x 10 9 /L 3000/mm3 or absolute neutrophil count of 1.2 x 10 9 /L 1200/mm3 at screening visit or within 3 months prior to baseline. 3. Thrombocytopenia, as defined by a platelet count 100 x 10 9 /L 100,000/mm3 at screening visit or within 3 months prior to baseline. 4. Estimated creatinine clearance 50 mL/hr by Cockroft Gault equation Appendix F at screening visit. 5. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening visit. For All subjects 6. Pregnant or lactating women. 7. Current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 8. History of an infected joint prosthesis at any time, with the prosthesis still in situ. 9. History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, as reported in some patients on other immunosuppressive drugs , history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease. 10. History of untreated infection with M. tuberculosis TB as defined by any of the following a. Chest radiograph taken within the 12 months prior to the baseline visit that has changes suggestive of active TB b. A positive tuberculin PPD skin test, which must have been performed and evaluated by a trained health professional within the 12 months prior to the baseline visit regardless of BCG vaccination status with 5 mm of induration without adequate anti TB therapy c. Immuno-reactivity to M tuberculosis by QuantiFERON Gold test 11. Patients with clinically significant infections within the 6 months prior to the baseline visit those requiring hospitalization, requiring parenteral antimicrobial therapy or judged to be opportunistic by the investigator , or those with recurrent oral or genital herpes, or as otherwise judged by the investigator. 12. Any other condition which would make the patient unsuitable for inclusion in the study. 13. A patient who has received any experimental therapy or biological therapies for RA within or outside a clinical trial within 6 months prior to the baseline visit, with the exception of experimental NSAIDs, coxibs, or opioids which may have been used up to 28 days prior to baseline. 14. Any prior treatment with lymphocyte depleting agents/therapies such as CAMPATH, alkylating agents eg, cyclophosphamide or chlorambucil , total lymphoid irradiation, etc. . Subjects who have received rituximab are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD20 counts by FACS analysis. 15. Intra-articular, intramuscular, or intravenous corticosteroids in the 4 weeks preceding baseline. 16. Patients with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or bariatric surgery such as gastric banding or gastric bypass. 17. History of alcohol or drug abuse with less than 6 months of sobriety prior to screening 18. Screening 12 lead electrocardiogram ECG that demonstrates clinically relevant abnormalities that may affect patient

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

Health Condition(s) or Problem(s) studied

Relief of signs and symptoms, improvement of physical function, and structure preservation in rheumatoid arthritis RA .
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Intervention(s)

Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): Primary endpoints will be standard laboratory safety data chemistry, hematology, etc. and adverse event AE reports.

Main Objective: To determine the long term safety and tolerability of 5 mg BID of CP-690,550 for treatment of the signs and symptoms of RA.

Secondary Objective: To evaluate the persistence of efficacy of CP-690,550 for treatment of the signs and symptoms of RA.

Secondary ID(s)

2006-005035-19-BE

A3921024