PoC in Rheumatoid Arthritis With Methotrexate

NCT00605735 | Completed Phase 2 DMC

• 1 other identifier: IM119-015
• Study Type: interventional
• Target: 121
• Locations: 8 countries
• Sites: 28

Brief Summary

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

Conditions

Rheumatoid Arthritis, NOS

Outcome Measures

Primary Outcomes (1)

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

  at Week 12

Secondary Outcomes (7)

• Proportion of subjects achieving an ACR 20

  at each scheduled visit

• Proportion of subjects schieving and ACR 50

  at each scheduled visit

• Proportion of subjects schieving and ACR 70

  at each scheduled visit

• Percent change from baseline to each scheduled visit in DAS28 score

  at each scheduled visit

• Percent change from baseline to each scheduled visit in ACR scores

  at each scheduled visit

Study Arms (2)

A1

EXPERIMENTAL

Drug: BMS-582949

P1

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BMS-582949 DRUG

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

Also known as: P38 Inflamation

A1

Placebo DRUG

Tablets, Oral, placebo, once daily, 12 weeks

P1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (28)

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Orrin M. Troum,M D

Santa Monica, California, 90404, United States

Location

G. Timothy Kelly, Md

Las Vegas, Nevada, 81928, United States

Location

Health Research Of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

The Arthritis Group

Philadelphia, Pennsylvania, 19152, United States

Location

Arthritis Clinic

Jackson, Tennessee, 38305, United States

Location

Walter F Chase Md

Austin, Texas, 78705, United States

Location

Tacoma Center For Arthritis Research Ps

Tacoma, Washington, 98405, United States

Location

Local Institution

Buenos Aires, Buenos Aires, 1426, Argentina

Location

Local Institution

Capital Federal, Buenos Aires, 1431, Argentina

Location

Local Institution

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1034ACO, Argentina

Location

Local Institution

České Budějovice, 370 01, Czechia

Location

Local Institution

Hradec Králové, 500 05, Czechia

Location

Local Institution

Prague, 128 50, Czechia

Location

Local Institution

Bordeaux, 33076, France

Location

Local Institution

Chambray-lès-Tours, 37170, France

Location

Local Institution

Paris, 75679, France

Location

Local Institution

Guadalajara, Jalisco, 44200, Mexico

Location

Local Institution

Guadalajara, Jalisco, 44500, Mexico

Location

Local Institution

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution

Nuevo León, Nuevo León, 64020, Mexico

Location

Local Institution

Culiacán, Sinaloa, 8000, Mexico

Location

Local Institution

Cheonan, Choong Chung Nam-Do, 330-721, South Korea

Location

Local Institution

Madrid, 28046, Spain

Location

Local Institution

Santiago de C., 15706, Spain

Location

Local Institution

Vizcaya, 48903, Spain

Location

Local Institution

Taichung, B, Taiwan

Location

Local Institution

Taoyuan District, 333, Taiwan

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid; Pyloric Stenosis, Hypertrophic

Interventions

4-(5-(cyclopropylcarbamoyl)-2-methylphenylamino)-5-methyl-N-propylpyrrolo(1,2-f)(1,2,4)triazine-6-carboxamide

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 12, 2015

Record last verified: 2015-09

Locations

ME (5); KR (1); AR (3); US (8); ES (3); TW (2); FR (3); CZ (3)