E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Rheumatoid Arthritis (RA) is an inflammatory disease that chiefly affects patients’ joints |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 |
The primary objectives are to assess the efficacy (as measured by the reduction of the signs and symptoms of RA) and the safety and tolerability of JNJ-39758979 at doses of 10, 30, 100, or 300 mg/d compared with placebo in subjects with active RA despite concomitant methotrexate (MTX) therapy. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
- To evaluate the maintenance of JNJ-39758979 efficacy - To assess the safety of JNJ-39758979 over 1 year - To characterize the population pharmacokinetics (PK) and exposure/response relationship of JNJ-39758979 in adults with RA on a stable dose of MTX |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
An optional intensive PK sub-study will be conducted at selected sites in subjects who sign a separate consent form. Blood samples will be collected for measurement of whole blood and plasma concentrations of JNJ–39758979 and its metabolites at predose and at 2, 3, 4, 6, 8, and 12 hours post dose.
The objective of this sub study is to evaluate the pharmacokinetics of JNJ-39758979 and/or its metabolites.
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E.3 | Principal inclusion criteria |
Principal Inclusion Criteria in Lay Language (for a complete list of inclusion criteria refer to the protocol):
- Be a man or woman between 18 and 80 years of age, inclusive.
- Has a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening.
-Positive test for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening.
- Has active RA defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints at the time of screening and at baseline; and serum C-reactive protein >= 0.70 mg/dL at screening.
- Has been treated with and tolerated methotrexate (MTX) at dosages from 10 to 25 mg/week, inclusive (6 to 16 mg/week, inclusive, for patients in Japan), for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 8 weeks prior to screening.
- Must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control.
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E.4 | Principal exclusion criteria |
Principal Exclusion Criteria in Lay Language (for a complete list of exclusion criteria refer to the protocol):
- Has inflammatory diseases other than rheumatoid arthritis, such as Lupus
- Is currently receiving treatment for RA other than methotrexate, NSAIDS, corticosteroids, such as prednisone, or pain medicines.
- Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
- Has moderate to severe decrease in the functioning of your kidneys
- Has a recent (2 months) serious infection
- Has an active infection
- Has had cancer within the past 5 years (except certain skin or cervical conditions)
- Has abused substances or alcohol with the past 2 years
– Has active Hepatitis B or C infection.
- Has had active tuberculosis.
- Has had exposure to tuberculosis without preventative treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is change from baseline in DAS28 (CRP) at Week 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary Efficacy Endpoints include:
-Change from baseline in DAS28 (CRP) at Week 24 -Change from baseline in DAS28 (ESR) at Week 12 and Week 24 -DAS28 (CRP) response rates at Week 12 and Week 24 -DAS28 (ESR) response rates at Week 12 and Week 24 -DAS28 (CRP) remission rates at Week 12 and Week 24 -ACR20/50/70 response rates at Week 12 and Week 24 -Hybrid ACR response at Week 12 and Week 24 -ACR/EULAR remission rates at Week 12 and Week 24 -Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24 -Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24 -HAQ-DI response at Week 12 and Week 24 -Change from baseline in HAQ-DI score at Week 12 and Week 24 -Percent change from baseline in ESR levels at Week 12 and Week 24 -Percent change from baseline in ACR components at Week 12 and Week 24 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Please refer to section E.5.2. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
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 | No |
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 |
Argentina |
Chile |
Colombia |
Czech Republic |
Japan |
Latvia |
Malaysia |
Mexico |
Poland |
Romania |
Russian Federation |
Singapore |
Ukraine |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |