Clinical Research Details

Phase III, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Two Doses of CP-690,550 in Patients With Active Rheumatoid Arthritis on Background DMARDS, Study Number: A3921046

This study is designed to provide one year of safety data and pivotal efficacy data in support of the proposed United States claims of reducing signs and symptoms and improvement in physical function for CP-690,550, dosed at 5 and 10 mg BID in patients with RA who have had an inadequate response to a DMARD (traditional or biologic), and similar claims within other jurisdictions. Patients must remain on at least one stably dosed, background traditional DMARD other than a potent immunosuppressive (such as azathioprine or cyclosporine) and must have washed out of all potent immunosuppressives and biologic response modifiers.

201715

750

1. Participants must be at least 18 years old at the screening visit.
2. Participants must have rheumatoid arthritis with evidence of disease activity by joint counts and laboratory markers of inflammation.
3. Participants must have ongoing treatment with a traditional background DMARD (call site for details)
4. Participants must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis (RA) 9 by satisfying at least four of the seven criteria and must meet Class I, II or III of the ACR 1991.
5. Participants must have active disease at both screening and baseline, as defined by having both:
a.. >four tender/painful joints on motion (out of 68 joints assessed); and
b. >four swollen joints (out of 66 joints assessed).
6. Participants must have active disease as defined fulfilling one of the two following criteria at screening only:
a. ESR (Westergren method) >28 mm/hr; or
b. C-reactive protein (CRP) >7 mg/L in the central laboratory.
7. All local standard-of-care practices for the administration of background DMARD therapy, including laboratory testing, follow-up care and contraindications should be performed according to local standards of care throughout the study.
8. Participants must have had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
9. Participants must remain on at least one background traditional DMARD, be dosed in accordance with the local regulatory label and be willing to remain on that
traditional DMARD throughout the course of the study. Combination therapy will
be allowed as consistent with local standards. (Call for additional details.)
10. Participants must have no evidence of active, latent or inadequately treated
infection with Mycobacterium tuberculosis (TB).
Exclusion Criteria
1. History of any other rheumatic autoimmune disease other than Sjogren’s syndrome.
2. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
3. 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.
4. History of recurrent (more than one episode) herpes zoster, disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
5. History of infection requiring hospitalization, parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator, within the six months prior to the first dose of study drug.
6. History of any infection requiring antimicrobial therapy within two weeks prior to the first dose of study drug.
7. Any prior treatment with non-B-cell-specific lymphocyte-depleting agents/therapies [e.g., alemtuzumab, alkylating agents (e.g., cyclophosphamide or
chlorambucil), total lymphoid irradiation, etc]. Patients 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 one year prior to study baseline and have normal CD 19/20+ counts by FACS analysis.
Other specific inclusion and exclusion criteria are available from the Loyola Clinical Trials Office, (708) 216-2027.

During this study, you will get either 5 mg twice a day of the study drug, 10 mg twice a day of the study drug or a placebo twice a day. The placebo is a pill that looks the same as the study drug but does not contain any drug. You have an 80 percent chance of getting the study drug. This means that one out of five people will get a placebo and four out of five people will get the study drug for the first three months of the study. However, at Month 3, if you were receiving the placebo and your arthritis has improved a little, not improved or gotten worse (based on the doctor’s examination of your joints), you will probably be advanced to receive either 5 mg or 10 mg of the study drug twice a day. If you are advanced to a new dose, the tablets will look exactly the same so neither you nor your doctor will know if you have been advanced. At Month 6, you will be advanced to either 5 mg or 10 mg of the study drug. Neither you nor the study doctor will not know if you are getting a placebo or the study drug during the first three months or the dose of the study drug you will be getting for the rest of the study. (708) 216-2027

Ruth Kadanoff, M.D.,Ph.D.

(708) 216-2026