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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: Abatacept (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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).

Clinical Details

Official title: A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

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

Secondary outcome:

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

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

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

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

Number of Participants With Persistent Symptomatic Clinical Synovitis

Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline

Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months

Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time

Frequency of Human Leukocyte Antigen (HLA) Typing

DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline

Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)

Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response

Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths

Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Locations and Contacts

Local Institution, Bruxelles, Belgium

Local Institution, Leuven, Belgium

Local Institution, Paris, France

Local Institution, Strasbourg Cedex, France

Local Institution, Berlin, Germany

Local Institution, Dresden, Germany

Local Institution, Hamburg, Germany

Local Institution, Hannover, Germany

Local Institution, Heidelberg, Germany

Local Institution, Bari, Italy

Local Institution, Ferrara, Italy

Local Institution, Milano, Italy

Local Institution, Ponce, Puerto Rico

Local Institution, A Coruna, Spain

Local Institution, Barcelona, Spain

Local Institution, Madrid, Spain

Local Institution, Oviedo, Spain

Local Institution, Sevilla, Spain

Local Institution, Huntsville, Alabama, United States

Local Institution, Mobile, Alabama, United States

Local Institution, Huntington Beach, California, United States

Local Institution, Los Angeles, California, United States

Local Institution, Boulder, Colorado, United States

Local Institution, Colorado Springs, Colorado, United States

Local Institution, Guadalajara, Distrito Federal, Mexico

Local Institution, Ft. Lauderdale, Florida, United States

Local Institution, Leon, Guanajuato, Mexico

Local Institution, Chicago, Illinois, United States

Local Institution, Evansville, Indiana, United States

Local Institution, Guadalajara, Jalisco, Mexico

Local Institution, New Orleans, Louisiana, United States

Local Institution, Cumberland, Maryland, United States

Local Institution, Hagerstown, Maryland, United States

Local Institution, Liverpool, Merseyside, United Kingdom

Local Institution, Morelia, Michioacan, Mexico

Local Institution, Duluth, Minnesota, United States

Local Institution, Durham, North Carolina, United States

Local Institution, Wilmington, North Carolina, United States

Local Institution, Leeds, North Yorkshire, United Kingdom

Local Institution, Oklahoma City, Oklahoma, United States

Local Institution, Willow Grove, Pennsylvania, United States

Local Institution, Cairns, Queensland, Australia

Local Institution, Charleston, South Carolina, United States

Local Institution, Austin, Texas, United States

Local Institution, Clayton, Victoria, Australia

Local Institution, Malvern, Victoria, Australia

Local Institution, Arlington, Virginia, United States

Local Institution, Shenton Park, Western Australia, Australia

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Related publications:

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. Erratum in: Ann Rheum Dis. 2011 Aug;70(8):1519.

Starting date: February 2005
Last updated: March 18, 2015

Page last updated: August 23, 2015

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