Clinical Trials/NCT01225393

NCT01225393

Completed

Phase 2

A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis

Genentech, Inc.0 sites211 target enrollmentNovember 2010

ConditionsRheumatoid Arthritis

Interventionsleflunomide methotrexate adalimumab MLTA3698A placebo

DrugsMLTA3698A adalimumab leflunomide methotrexate placebo

Overview

Phase: Phase 2
Intervention: leflunomide
Conditions: Rheumatoid Arthritis
Sponsor: Genentech, Inc.
Enrollment: 211
Primary Endpoint: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

July 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening
•Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both
•Active disease, defined as: CRP \>= 1.0 mg/dL; swollen joint count \>= 6 (66 joint count); tender joint count \>= 6 (68 joint count)
•Previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU)
•For patients currently receiving corticosteroids: Treatment at a stable dose during last 4 weeks prior to screening
•For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening
•For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose
•For patients of reproductive potential (males and females): Willing to use a highly effective birth control method for the duration of the study according to local guidelines

Exclusion Criteria

•Pregnant, planning to become pregnant during the study, or breastfeeding
•Clinically significant abnormal laboratory values or abnormal ECG or vital signs
•History of anaphylactic reactions
•Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome), however patients with secondary Sjogren's syndrome are eligible for the study
•History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome)
•Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis
•Administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study
•Previous treatment with anti-TNF biologics or other biologic agents, including anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g. tocilizumab), or T cell-directed therapy (e.g. abatacept)

Arms & Interventions

A

Intervention: leflunomide

A

Intervention: methotrexate

B

Intervention: adalimumab

B

Intervention: leflunomide

A

Intervention: MLTA3698A

B

Intervention: methotrexate

B

Intervention: placebo

C

Intervention: leflunomide

C

Intervention: methotrexate

C

Intervention: placebo

Outcomes

Primary Outcomes

Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR

Time Frame: Day 85

Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A

Time Frame: Length of study (through Day 85)

Secondary Outcomes

ACR20 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 20% responder criteria [ACR20] for their average response )(Day 85)
ACR70 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 70% responder criteria [ACR70] for their average response)(Day 85)
ACR50 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 50% responder criteria [ACR50] for their average response )(Day 85)
Tender joint count(Day 85)
Swollen joint count(Day 85)
Investigator Global Assessment of Disease Activity(Day 85)
Patient Global Assessment of Pain and Disease Activity(Day 85)
Health Assessment Questionnaire Disability Index(Day 85)
Patient's Global Health or Short Form Health Survey (SF-36)(Day 85)
European League Against Rheumatism response rate(Day 85)
Serum C-reactive protein levels(Day 85)
Erythrocyte sedimentation rate(Day 85)