Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

NCT00124449 | Completed Phase 2 Results

• 1 other identifier: IM101-046
• Study Type: interventional
• Target: 56
• Locations: 10 countries
• Sites: 48

Brief Summary

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy

  ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.

  12 months

Secondary Outcomes (14)

• Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy

  24 months

• Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease

  12 months, 24 months

• Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months

  Baseline, 6 months, 12 months, 24 months

• Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months

  Baseline, 6 months, 12 months, 24 months

• Number of Participants With Persistent Symptomatic Clinical Synovitis

  6, 12, and 24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Abatacept

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Abatacept DRUG

solution, intravenous injection, monthly, 169 days weight based: \<60 kg = 500 mg 60 to 100 kg = 750 mg \>100 kg = 1 g

Also known as: Orencia

1

placebo DRUG

solution, intravenous injection, 0 mg, monthly, 169 days

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of undifferentiated arthritis
• Clinical synovitis of two or more joints
• At least one but not more than three of the criteria for diagnosis of RA (1987).
• No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
• Duration of disease must be 18 months or less.
• Positive for antibodies against cyclic citrullinated peptides.

You may not qualify if:

• Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy.
• Active vasculitis of a major organ system.
• Severe or recurrent bacterial infection.
• History of cancer in the last five years except certain skin cancers.
• Herpes zoster that resolved less than 2 months prior to enrollment

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (48)

Local Institution

Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Fort Lauderdale, Florida, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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New Orleans, Louisiana, United States

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Cumberland, Maryland, United States

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Hagerstown, Maryland, United States

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Duluth, Minnesota, United States

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Durham, North Carolina, United States

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Wilmington, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Willow Grove, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Arlington, Virginia, United States

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Cairns, Queensland, Australia

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Clayton, Victoria, Australia

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Malvern, Victoria, Australia

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Shenton Park, Western Australia, Australia

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Brussels, Belgium

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Leuven, Belgium

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Paris, France

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Strasbourg, France

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Berlin, Germany

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Dresden, Germany

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Hamburg, Germany

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Hanover, Germany

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Heidelberg, Germany

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Bari, Italy

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Ferrara, Italy

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Milan, Italy

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León, Guanajuato, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Mexico City, Mexico

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Morelia, Michioacan, Mexico

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Ponce, Puerto Rico

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A Coruña, Spain

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Barcelona, Spain

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Madrid, Spain

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Oviedo, Spain

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Seville, Spain

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Liverpool, Merseyside, United Kingdom

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Leeds, North Yorkshire, United Kingdom

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Related Publications (1)

• Emery P, Durez P, Dougados M, Legerton CW, Becker JC, Vratsanos G, Genant HK, Peterfy C, Mitra P, Overfield S, Qi K, Westhovens R. Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar;69(3):510-6. doi: 10.1136/ard.2009.119016. Epub 2009 Nov 23.

  PMID: 19933744 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 28, 2005
• Study Start: February 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: April 1, 2008
• Last Updated: April 7, 2015
• Results First Posted: November 19, 2009

Record last verified: 2015-03

Locations

ES (5); FR (2); ME (4); IT (3); PR (1); DE (5); AU (4); US (20); GB (2); BE (2)