Rheumatoid Arthritis MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870
Conditions
Interventions
Product Name: CNTO6785
Product Code: CNTO6785
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: CNTO6785
Current Sponsor code: CNTO6785
Concentration unit: mg milligram
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Be a man or woman between 18 (at least 18 and the legal age of consent in the jurisdiction in which the study is taking place) and 80 years of age (or less if mandated by country-specific guidelines), inclusive. • Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening. • Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) = 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) = 28 mm in the first hour at screening or baseline. • Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent. 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: •Has inflammatory diseases other than RA, including, but not limited to adult onset Still’s disease (AOSD), Felty’s syndrome, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy. • Has a history of juvenile idiopathic arthritis (JIA). •Has a diagnosis of fibromyalgia. • Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant. • At screening, the results of laboratory tests must meet protocol-specified criteria. • Has ever received any approved or investigational biologic agent for a rheumatic indication including, but not limited to, brodalumab (AMG 827), infliximab, xekizumab, secukinumab, etanercept, adalimumab, golimumab, sirukumab, certolizumab pegol, tocilizumab, abatacept, anakinra, yisaipu, and ß-cell depleting therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of CNTO 6785 on the signs and symptoms in subjects with active RA compared with placebo despite concomitant methotrexate (MTX) therapy;Secondary Objective: 1. To assess the safety and tolerability of CNTO 6785 2. To assess the impact of CNTO 6785 on physical function 3. To assess the pharmacokinetics (PK) and immunogenicity of CNTO 6785 4. To explore PK/pharmacodynamic (PD) relationship ;Primary end point(s): The proportion of participants who achieve an ACR 20 response ;Timepoint(s) of evaluation of this end point: At Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Change from baseline in DAS28 (CRP) 2.The proportion of participants who achieve ACR 50 response 3.The proportion of participants who achieve ACR 20/50/70 responses 4.Change from baseline of DAS28 (CRP) 5.The proportion of participants with DAS28 (CRP) response 6.The proportion of participants with DAS28 (CRP) remission 7.Change from baseline in DAS28 (ESR) 8.Change from baseline in HAQ-DI score 9.Change from baseline in SF-36 10.Change from baseline in CDAI 11.Change from baseline in SDAI 12.The proportion of participants with SDAI-based ACR/EULAR remission 13.The proportion of participants with Boolean-based ACR/EULAR remission ;Timepoint(s) of evaluation of this end point: 1. At Week 16 2. At Week 16 3. Through Week 32 4. Through Week 32 5. Through Week 32 6. At Weeks 16 and 32 7. At Weeks 16 and 32 8. Through Week 32 9. At Weeks 16 and 32 10. At Weeks 16 and 32 11. At Weeks 16 and 32 12. At Weeks 16 and 32 13. At Weeks 16 and 32 | — |
Countries
Argentina, China, Colombia, Czech Republic, India, Philippines, Poland, Russian Federation, Thailand
Contacts
Public ContactClinical Registry Group
Janseen-Cilag International NV
Outcome results
None listed