Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint Disease

Part of paid clinical trials in San Francisco, California.

Sponsor
Jonathan Graf
Study ID
NCT01893996
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Patients will be randomized 1:1 to receive either adalimumab or placebo for the first 26 weeks of the trial, and then after a 26 week washout period, will be crossed over into the other arm (either placebo or adalimumab) for weeks 52-78.
  • Placebo — DRUG

Study Details

Rheumatoid arthritis patients are at increased risk of cardiovascular disease because of systemic inflammation that can persist even in patients with well-controlled joint disease. We hypothesize that adding an anti-tumor necrosis factor medication, adalimumab, to standard non-biologic therapy for rheumatoid arthritis will improve endothelial function (reduce cardiovascular risk) in these patients. The design of the trial is as follows: 18 month prospective, randomized, double-blind crossover trial comparing the addition of adalimumab to the addition of placebo. The primary endpoint is a change in endothelial cell function, as detected by brachial artery FMD, at 6 months of adalimumab treatment compared to 6 months of placebo.

Key Dates

Start date
Jul 31, 2013
Status verified
Apr 2021
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017

Study Design

Enrollment
63 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Adalimumab
    Active Study Drug is Adalimumab (Humira) which is FDA approved to treat rheumatoid arthritis since 2003.
  • Placebo Comparator: Placebo
    Placebo is inert and matches study drug, including the pre-filled syringe, and is supplied by Abbvie, the study drug manufacturer.

Primary Outcome Measure

Change in Endothelial Function [ Time Frame: Weeks 0, 13, 26, 52, 65, 78 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Francisco/San Francisco General HospitalSan FranciscoCalifornia94110-

Find similar trials in San Francisco, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of California San Francisco/San Francisco General Hospital· San Francisco, CA

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