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Completed

NCT Number: NCT00605735

PoC in Rheumatoid Arthritis With Methotrexate

The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate

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Key information

Conditions

Rheumatoid Arthritis, NOS Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Digestive System Diseases Gastric Outlet Obstruction Gastrointestinal Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Pyloric Stenosis Pyloric Stenosis, Hypertrophic Rheumatic Diseases Skin and Connective Tissue Diseases Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have a diagnosis of RA for at least 6 months
  • Must be taking methotrexate for at least 3 months & on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
  • Must have at least 6 swollen and at least 8 tender joints
  • CRP above upper limit of normal or ESR > 28 mm/hr
  • Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication

Exclusion criteria

  • Any infection including TB, HIV, Hepatitis B or C
  • Recent infection requiring antibiotics within 4 weeks
  • History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
  • Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)

Treatment and study plan

BMS-582949

Drug

Tablets, Oral, 300 mg, once daily, 12 weeks

Other names: P38 Inflamation

Placebo

Drug

Tablets, Oral, placebo, once daily, 12 weeks

Primary outcomes

  1. The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12

    Time frame: at Week 12

Secondary outcomes

  1. Proportion of subjects achieving an ACR 20

    Time frame: at each scheduled visit

  2. Proportion of subjects schieving and ACR 50

    Time frame: at each scheduled visit

  3. Proportion of subjects schieving and ACR 70

    Time frame: at each scheduled visit

  4. Percent change from baseline to each scheduled visit in DAS28 score

    Time frame: at each scheduled visit

  5. Percent change from baseline to each scheduled visit in ACR scores

    Time frame: at each scheduled visit

  6. Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue

    Time frame: at each scheduled visit

  7. Percent change from baseline to each scheduled visit in HAQ score

    Time frame: at each scheduled visit

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 31, 2008
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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