The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients

Sponsor
Heinrich-Heine University, Duesseldorf
Study ID
NCT02150473
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    adalimumab 40 mg every other week in combination with MTX for 24 weeks
  • Placebo — DRUG
    Placebo the same amount as adalimumab

Study Details

This study aims to compare longitudinally the effect of adalimumab plus methotrexate (MTX) versus MTX monotherapy on cartilage GAG content, reflected by Delayed Gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) index, in patients with early progressive rheumatoid arthritis (RA), who had not previously received any Disease modifying antirheumatic drug (DMARD) or biologic treatment.

Key Dates

Start date
Oct 31, 2014
Status verified
Oct 2017
Primary completion
Sep 14, 2017
Completion
Sep 14, 2017

Study Design

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

Arms

  • Experimental: Adalimumab
    receive adalimumab 40 mg eow injections in combination with MTX for 24 weeks
  • Placebo Comparator: Placebo
    receive placebo injections in combination with MTX for 24 weeks

Primary Outcome Measure

Joint space narrowing of the metacarpophalangeal (MCP II) and MCP III joints in the clinically dominant hand measured by variable flip-angle imaging 3 time (3T) MRI [ Time Frame: 104 weeks ]

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