Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: JNJ-39758979-AAC - enteric coated tablet - 10 mg
Product Code: JNJ-39758979
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Curren
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: Please refer to section E.5.2. | — |
Primary
| Measure | Time frame |
|---|---|
| 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: - 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;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 | — |
Countries
Argentina, Chile, Colombia, Czech Republic, Japan, Latvia, Malaysia, Mexico, Poland, Romania, Russian Federation, Singapore, Ukraine, United States
Contacts
Public ContactClinical Registry Group
Janssen Research and Development, a Division of Janssen Pharmaceutica NV
Outcome results
None listed