Rheumatoid Arthritis MedDRA version: 15.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have had RA for at least 6 months prior to screening - Have a diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association - Be positive for either anticyclic citrullinated peptide antibody or rheumatoid factor in serum at screening. - Have been treated with and tolerated MTX for at least 6 months prior to screening, and have a MTX dose of >= 10 mg and = 0.80 mg/dL at screening. The investigator may consider the patient eligible if the CRP value is at least 0.80 mg/dL in a single repeat testing during the screening period. - If using oral corticosteroids, must be on a stable dose of =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - Has other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of study agent therapy. - 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 any known malignancy or history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent). - Has a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly. – Has known allergies, hypersensitivity, or intolerance to ustekinumab or CNTO 1959 or its inactive ingredients - Tests positive for hepatitis B virus (HBV) infection or has antibodies to hepatitis C virus (HCV) at screening - Is infected with human immunodeficiency virus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in subjects with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.;Secondary Objective: The secondary objectives are to evaluate the pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of ustekinumab and CNTO 1959 in subjects with active RA despite concomitant MTX therapy. ;Primary end point(s): The primary endpoint is proportion of subjects who achieve ACR 20 response at Week 28.;Timepoint(s) of evaluation of this end point: Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Primary secondary end points: 1. Change from baseline in DAS28 (using CRP) score at Week 28 2. ACR20 response at Week 12 3. Change from baseline in HAQ-DI score at Week 28 ;Timepoint(s) of evaluation of this end point: Week 12 and Week 28 | — |
Countries
Argentina, Bulgaria, Chile, Colombia, Czech Republic, Hungary, Korea, Democratic People's Republic of, Mexico, Peru, Russian Federation, Singapore, Turkey, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed