E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Supplemento del profilo molecolare opzionale |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |