A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid Arthritis
- Conditions
- Rheumatoid ArthritisMedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-002849-36-LV
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 325
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.
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 275
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: The secondary objectives are:<br><br>- To evaluate the maintenance of JNJ-39758979 efficacy<br>- To assess the safety of JNJ-39758979 over 1 year<br>- To characterize the population pharmacokinetics (PK) and exposure/response relationship of JNJ-39758979 in adults with RA on a stable dose of MTX;Primary end point(s): The primary endpoint is change from baseline in DAS28 (CRP) at Week 12;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Efficacy Endpoints include:<br><br>-Change from baseline in DAS28 (CRP) at Week 24<br>-Change from baseline in DAS28 (ESR) at Week 12 and Week 24<br>-DAS28 (CRP) response rates at Week 12 and Week 24<br>-DAS28 (ESR) response rates at Week 12 and Week 24<br>-DAS28 (CRP) remission rates at Week 12 and Week 24<br>-ACR20/50/70 response rates at Week 12 and Week 24<br>-Hybrid ACR response at Week 12 and Week 24<br>-ACR/EULAR remission rates at Week 12 and Week 24<br>-Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24<br>-Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24<br>-HAQ-DI response at Week 12 and Week 24<br>-Change from baseline in HAQ-DI score at Week 12 and Week 24<br>-Percent change from baseline in ESR levels at Week 12 and Week 24<br>-Percent change from baseline in ACR components at Week 12 and Week 24;Timepoint(s) of evaluation of this end point: Please refer to section E.5.2.