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A 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 Patients With Active Rheumatoid Arthritis

NCT01225393 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2016-11-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

MLTA3698A

Subcutaneous repeating dose

DRUG

adalimumab

Subcutaneous repeating dose

DRUG

leflunomide

Stable dose if not on methotrexate

DRUG

methotrexate

Stable dose if not on leflunomide

DRUG

placebo

Subcutaneous repeating dose

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • John C. Davis, Jr., M.D., M.P.H. · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-07-31

Countries

  • United States
  • Bulgaria
  • Chile
  • Germany
  • Hungary
  • Mexico
  • Peru
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225393 on ClinicalTrials.gov