PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-014296-40-IT
• Date of registration: 08/02/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY 10017
• Public title: PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS - ND
• Scientific title: PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS - ND
• Date of first enrolment: 08/06/2010
• Target sample size: 396
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014296-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Belgium, France, Germany, Ireland, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
- Active rheumatoid arthritis (RA) - Ongoing treatment with an adequate and stable dose of methotrexate - In the opinion of the investigator, at least one approved TNF-inhibiting biologic agent administered in accordance with its labeling recommendations was inadequately effective and/or not tolerated. - Must be at least 18 years of age - No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) - For traditional DMARDS, minimum washout criteria apply
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:
- Any prior treatment with non B lymphocyte-selective lymphocyte depleting agents/therapies - Blood dyscrasias - Estimated GFR less than 40 ml/min - AST or ALT more than 1.5 times the upper limit of normal at screening visit - Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, or neurological disease - History of any other autoimmune rheumatic disease other than Sjogren s syndrome - History of an infected joint prosthesis at any time, with the prosthesis still in situ. - History of any lymphoproliferative disorder - History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug - History of any infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug - A history of recurrent (more than one episode) herpes zoster, disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex. - . A patient who was vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, expects to be vaccinated or exposed to these vaccines during treatment, or during the 6 weeks following discontinuation of study drug.


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

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis
MedDRA version: 9.1 Level: PT Classification code 10039073

Intervention(s)

Product Code: CP-690,550
Pharmaceutical Form: Film-coated tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: 1. To compare the efficacy of CP-690,550, in doses of 5 mg BID and 10 mg BID, versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA), in subjects with RA on background methotrexate who have had an inadequate response to a TNF inhibitor, as measured by ACR20 response rates at Month 3. 2. To compare physical function status of patients with active RA on background methotrexate who have had an inadequate response to a TNF inhibitor, after administration of CP-690,550, in doses of 5 mg BID and 10 mg BID, versus placebo, as measured by the HAQ-DI response at Month 3. 3. To compare the safety and tolerability of CP-690,550, in doses of 5 mg BID and 10 mg BID, versus placebo in patients with RA on background methotrexate who have had an inadequate response to a TNF inhibitor.

Primary end point(s): 1. American College of Rheumatology 20 (ACR20) responder rate versus placebo at the Month 3 visit. 2. Change from baseline in the Health Assessment Questionnaire (HAQ-DI) vs. placebo at the Month 3 visit.

Secondary Objective: 1. To compare the efficacy of CP-690,550, in doses of 5 mg BID and 10 mg BID, versus placebo for the treatment of signs and symptoms of RA in subjects with RA on background methotrexate who have had an inadequate response to a TNF inhibitor at all other time points as measured by ACR20, ACR50, ACR70 and DAS 28 response rates. 2. To compare the durability of ACR20, ACR50, and ACR70 and DAS 28 response rates. 3. To compare the incidence of DAS 28 remission and low disease activity state at each visit. 4. To compare effects on all health outcomes measures in the study at each visit, as appropriate for the specific outcome, compared to baseline.

Secondary ID(s)

A3921032

2009-014296-40-DE