BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis - Full Text View

Purpose

The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

Condition	Intervention	Phase
Juvenile Rheumatoid Arthritis	Drug: Abatacept Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis

MedlinePlus related topics: Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Comparison of efficacy of abatacept vs placebo in children and adolescents with JRA/JIA in whom a response had been initially induced [ Time Frame: 4 months of open-label therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the following will be assessed after 6 months of double-blind therapy: clinical efficacy as measured by the proportion of subjects that demonstrate JRA/JIA disease flare by Day 169; [ Time Frame: after 6 months of double-blind therapy ] [ Designated as safety issue: No ]

Enrollment:	122
Study Start Date:	February 2004
Study Completion Date:	November 2011
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Abatacept Double Blind Period	Drug: Abatacept IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier). Other Name: Orencia
Placebo Comparator: Placebo Double Blind Period	Drug: Placebo IV infusions, IV, N/A, every 4 weeks, 6 months.
Experimental: Abatacept - Open Label	Drug: Abatacept Solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly Other Name: Orencia

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Juvenile Rheumatoid Arthritis or Juvenile Idiopathic Arthritis;
Current active arthritis;
Failed treatment with at least one disease modifying anti-rheumatic drug (DMARD);
Subjects must discontinue use of any DMARD other than methotrexate prior to the first dose of study medication

Exclusion Criteria:

Presence of infection or history of frequent acute or chronic infections;
Joint replacement surgery required during the study or history of surgery on more than 5 joints;
Live vaccines within 3 months of the first dose of study medication;
Unresolved serious bacterial infection or chronic bacterial infection;
Subjects who currently have intermittent fever due to JRA/JIA, rheumatoid rash, hepato-splenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095173

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Locations

United States, Nebraska
Creighton University School Of Medicine
Omaha, Nebraska, United States, 68178
United States, New Jersey
Saint Barnabas Ambulatory Care Center
Livingston, New Jersey, United States, 07039
United States, New York
Schneider Children'S Hospital
New Hyde Park, New York, United States, 11040
New York Medical College
Valhalla, New York, United States, 10595
United States, Ohio
Children'S Hospital Medical Center Division Of Hematology
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Texas Scottish Rite Hospital
Dallas, Texas, United States, 75219
United States, Washington
Children'S Hospital And Regional Medical Center
Seattle, Washington, United States, 98105
United States, Wisconsin
Medical College Of Wisconsin, Inc
Milwaukee, Wisconsin, United States, 53226
Austria
Local Institution
Bregenz, Austria, 6900
Brazil
Local Institution
Rio De Janeiro, Rj, Brazil, 21941
Local Institution
Botucatu, Sao Paulo, Brazil, 18618
Local Institution
Sco Paulo, Sao Paulo, Brazil, 05403
Local Institution
Sao Paulo, Sp, Brazil, 01246
Local Institution
Sao Paulo, Sp, Brazil, 05651
Local Institution
Rio De Janeiro, Brazil, 20551
France
Local Institution
Le Kremlin Bicetre Cedex, France, 94275
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Paris Cedex 15, France, 75738
Local Institution
Strasbourg Cedex, France, 67098
Local Institution
Vandoeuvre Les Nancy, France, 54500
Germany
Local Institution
Berlin, Germany, 13353
Local Institution
Bremen, Germany, 28205
Local Institution
Halle, Germany, 06120
Local Institution
Hamburg, Germany, 22081
Italy
Local Institution
Firenze, Italy, 50132
Local Institution
Genova, Italy, 16147
Local Institution
Milano, Italy, 20122
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Napoli, Italy, 801031
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Roma, Italy, 00165
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Trieste, Italy, 34134
Mexico
Local Institution
Mexico City, Distrito Federal, Mexico, 06726
Local Institution
Guadalajara, Jalisco, Mexico, 44700
Local Institution
Guadalajara, Jalisco, Mexico, 42650
Local Institution
Monterrey, Nuevo Leon, Mexico, 64060
Local Institution
Puebla, Pue., Puebla, Mexico, 72190
Local Institution
San Luis Potosi, Mexico, 78240
Peru
Local Institution
Lima, Peru, LIMA 5
Local Institution
Lima, Peru, LIMA 11
Portugal
Local Institution
Lisboa, Portugal, 1200-667
Spain
Local Institution
A Coruna, Spain, 15006
Local Institution
Valencia, Spain, 46009
Switzerland
Local Institution
Lausanne, Switzerland, 1011

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ruperto N, Lovell DJ, Li T, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Alcala JO, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace C, Alessio M, Quartier P, Cortis E, Eberhard A, Simonini G, Lemelle I, Chalom EC, Sigal LH, Block A, Covucci A, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Abatacept improves health-related quality of life, pain, sleep quality, and daily participation in subjects with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1542-51. Epub 2010 Jul 1.

Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhães C, Chavez-Corrales J, Huemer C, Kivitz A, Blanco FJ, Foeldvari I, Hofer M, Horneff G, Huppertz HI, Job-Deslandre C, Loy A, Minden K, Punaro M, Nunez AF, Sigal LH, Block AJ, Nys M, Martini A, Giannini EH; Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis Rheum. 2010 Jun;62(6):1792-802.

Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhães C, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Orozco J, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace CA, Sigal LH, Block AJ, Covucci A, Martini A, Giannini EH; Paediatric Rheumatology INternational Trials Organization; Pediatric Rheumatology Collaborative Study Group. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008 Aug 2;372(9636):383-91. Epub 2008 Jul 14.

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00095173 History of Changes
Other Study ID Numbers:	IM101-033
Study First Received:	November 1, 2004
Last Updated:	December 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Juvenile Idiopathic Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013