A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS

• Conditions: Rheumatoid arthritis; MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2010-021577-37-DE
• Lead Sponsor: GENENTECH, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-29
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA (see Appendix C) for at least 6 months prior to screening
Age 18-75 years at screening
Body weight of 50–120 kg and body mass index of 19–35 kg/m2
Positive for rheumatoid factor or anti-CCP antibody, or both
Active disease, defined as presence of all of the following:
CRP = 1.0 mg/dL at screening
Swollen joint count = 6 (66 joint count) at screening and baseline (Day 1)
Tender joint count = 6 (68 joint count) at screening and baseline (Day 1)
Previous inadequate clinical response to at least one DMARD
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant, planning to become pregnant during the study, or breastfeeding
History of anaphylactic reactions
History of or currently active primary or secondary immunodeficiency, including known history of HIV infection
Positive QuantiFERON-TB Gold test (see Appendix L)
Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
Functional Class IV (ACR classification)
History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder
Malignancy, or prior malignancy
Previous treatment with MLTA3698A, ADA or other anti-TNF or biologic agents,
Current or recent infection,
History of recurrent significant infections
Hospitalization for a clinically relevant event within 4 weeks prior to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified