A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Phase 1

Conditions: Rheumatoid Arthritis
MedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-001417-32-LT

Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 510

Inclusion Criteria

1. Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening

2. Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline

3. Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX (including MTX-naïve subjects for whom it
is inappropriate to administer MTX), and/or are considered
inappropriate for treatment with MTX, and/or an inadequate responder to methotrexate

4. Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent

5. C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening
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 423
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 87

Exclusion Criteria

1. Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis

2. Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept

3. Has ever used tofacitinib therapy or any other JAK inhibitor

4. Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration

5. Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to demonstrate the superior efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active RA who are intolerant to MTX, who are considered inappropriate for treatment with MTX or who are inadequate responders to MTX.;Secondary Objective: The secondary objectives are to assess the following for sirukumab:<br>- Safety<br>- Physical function<br>- Pharmacokinetics, pharmacodynamics, and immunogenicity;Primary end point(s): 1. Change from baseline in Disease Activity Index Score 28 using erythrocyte sedimentation rate [DAS28 (ESR)]<br><br>2. Percentage of subjects with an American College of Rheumatology 50 (ACR 50) response ;Timepoint(s) of evaluation of this end point: 1, 2) at week 24

Secondary Outcome Measures