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

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT01225393
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MLTA3698A — DRUG
    Subcutaneous repeating dose
  • adalimumab — DRUG
    Subcutaneous repeating dose
  • leflunomide — DRUG
    Stable dose if not on methotrexate
  • methotrexate — DRUG
    Stable dose if not on leflunomide
  • placebo — DRUG
    Subcutaneous repeating dose

Study Details

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

Key Dates

Start date
Nov 30, 2010
Status verified
Nov 2016
Primary completion
Jul 31, 2012

Study Design

Enrollment
211 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Active Comparator: B
  • Placebo Comparator: C

Primary Outcome Measure

Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR [ Time Frame: Day 85 ]

Locations (14)

FacilityCityStateZIPSite coordinators
-AnnistonAlabama36207-
-BirminghamAlabama35216-
-PeoriaArizona85381-
-Los AngelesCalifornia90033-
-UplandCalifornia91786-
-Ormond BeachFlorida32174-
-LexingtonKentucky40515-
-KalamazooMichigan49009-
-FlowoodMississippi39232-
-RenoNevada89502-
-CharlestonSouth Carolina29406-
-San AntonioTexas78217-
-ChesapeakeVirginia23320-
-ClarksburgWest Virginia26301-

Find similar trials in Anniston, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

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