Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Novartis
Study ID
NCT00487825
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Canakinumab (investigational) — DRUG
    Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
  • Placebo — DRUG
    Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
  • Methotrexate (MTX) — DRUG
    Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.

Study Details

This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)

Key Dates

Start date
Mar 31, 2007
Status verified
Jul 2012
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

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

Arms

  • Experimental: Canakinumab + Methotrexate
    Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. MTX was given as variable dosing regimen of 7.5 mg-15 mg weekly.
  • Active Comparator: Methotrexate + placebo
    Methotrexate (MTX) was given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.

Primary Outcome Measure

Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50) [ Time Frame: 6, 14, and 26 weeks of treatment ]

Locations (17)

FacilityCityStateZIPSite coordinators
Rheumatology Associates of Northern Alabama (Dr. William Shergy)HuntsvilleAlabama35801-
Clinic for Rheumatic Diseases (Dr. Richard Jones, III)TuscaloosaAlabama35406-
Arizona Arthritis and Rheumatology Research (Dr. Paul Caldron)Paradise ValleyArizona85253-
Jacksonville Center for Clinical Research (Dr. Steven Mathews)JacksonvilleFlorida32216-
Center for Arthritis and Rheumatic Diseases (Dr. Michael Weitz)South MiamiFlorida33143-
West Broward Rheumatology Associates, Incorporated (Dr. Elias Halpert)TamaracFlorida33321-
Rockford Orthopedic Associates (Dr. Richard Olson)RockfordIllinois61107-
Mercy Arthritis and Osteoporosis Center (Dr. Alan Braun)UrbandaleIowa50322-
Clayton Medical Research (Dr. Iri Don)Richmond HeightsMissouri63117-
Westroads Medical Group (Dr. William Palmer)OmahaNebraska68114-
Arthritis Center of Reno (Dr. Malin Prupas)RenoNevada89502-
Oklahoma Center for Arthritis therapy and Research (Dr. James McKay)TulsaOklahoma74104-
MetaClin Research, Incorporated (Dr. Paul Pickrell)AustinTexas78704-
John M. Joseph, MD (Dr. John Joseph)CarltonTexas75007-
Southwest Rheumatology, P.A. (Dr. Atul Singhal)MesquiteTexas75150-
Arthritis Clinic of Northern Virginia (Dr. Philip Kempf)ArlingtonVirginia22205-
Arthritis Northwest Rheumatology, PLLC (Dr. Jeffrey Butler)SpokaneWashington99204-

Find similar trials in Huntsville, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Rheumatology Associates of Northern Alabama (Dr. William Shergy)· Huntsville, ALClinic for Rheumatic Diseases (Dr. Richard Jones, III)· Tuscaloosa, ALArizona Arthritis and Rheumatology Research (Dr. Paul Caldron)· Paradise Valley, AZJacksonville Center for Clinical Research (Dr. Steven Mathews)· Jacksonville, FLCenter for Arthritis and Rheumatic Diseases (Dr. Michael Weitz)· South Miami, FLWest Broward Rheumatology Associates, Incorporated (Dr. Elias Halpert)· Tamarac, FL

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