Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis

NCT00534313 | Terminated Phase 2 Results

• 2 other identifiers: IM101-158EUDRACT 2007-004241-15
• Study Type: interventional
• Target: 191
• Locations: 12 countries
• Sites: 44

Brief Summary

The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of active arthritis due to psoriatic arthritis in patients who have had a prior inadequate response to disease-modifying antirheumatic drugs, including methotrexate and tumor necrosis factor alpha-blockade compounds.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

• Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest

  Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.

  From Day 169 to Day 729

• Short-term Period: Number of Participants With ACR 20 Response at Day 169

  An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant's assessment of disease activity, participant's global assessment of disease activity, investigator's global assessment of disease activity, participant's assessment of physical function by HAQ-DI, and Disease Activity Score 28-C reactive protein.

  At Day 169 from Baseline

Secondary Outcomes (21)

• Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729

  At Days 365 and 729 from Baseline

• Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729

  From Day 169 to Days 365 and 729

• Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729

  From Baseline to Days 365 and 729

• Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729

  At Days 365 and 729 from baseline

• Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729

  Days 365 and 729 from baseline

Study Arms (4)

Abatacept (30/10)

ACTIVE COMPARATOR

Abatacept (30 mg/kg) was administered as intravenous (iv) infusion over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants for dosing on Days 1 and 15 followed by fixed dosing as per rheumatoid arthritis label (participants weighing \<60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \>100 kg received 1000 mg) thereafter.

Drug: Abatacept

Abatacept (10/10)

ACTIVE COMPARATOR

Abatacept (10 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 in the double-blind period and continued for next 18 months in the open-label period till Day 729. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing \<60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \>100 kg received 1000 mg).

Drug: Abatacept

Abatacept (3/3)

ACTIVE COMPARATOR

Abatacept (3 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants.

Drug: Abatacept

Placebo

PLACEBO COMPARATOR

Placebo solution (5% dextrose in water for injection, 0.9% sodium chloride injection) by iv infusion was administered on Days 1, 15, and 29 and every 28 days thereafter till Day 141.

Drug: Placebo

Interventions

Abatacept DRUG

Solution, intravenous, monthly, short-term = 24 weeks (6 months)

Also known as: Orencia, BMS-188667

Abatacept (10/10); Abatacept (3/3); Abatacept (30/10)

Placebo DRUG

Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)

Placebo

Eligibility Criteria

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

You may qualify if:

• Meeting classification criteria for psoriatic arthritis for a duration of disease of at least 3 months
• Prior failure (inefficacy or intolerance) of therapy with disease-modifying antirheumatic drugs; if patient had prior failure of methotrexate, he or she must have been taking at least 15 mg per week for at least 2 months
• If recent failure(inefficacy or intolerance) of a tumor necrosis factor α-blockade compound, participant must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab
• Disease activity as defined by a tender joint count of ≥3, swollen joint count of ≥3, and clinically detectable synovitis at screening and Day 01 (prior to infusion)
• Active psoriasis with a qualifying target lesion ≥2 cm in diameter
• Able to undergo magnetic resonance imaging
• Use of appropriate birth control by women of child bearing potential (WOCBP)

You may not qualify if:

• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of investigational product
• Women who are pregnant or breastfeeding or who plan to become pregnant or to start breastfeeding during the duration of the study
• Women with a positive pregnancy test on enrollment or prior to investigational product administration.
• Participants scheduled for or anticipating joint replacement surgery.
• Those with a recent history of clinically significant drug or alcohol abuse
• Concomitant illness that in the investigator's opinion is likely to require systemic glucocorticosteroid therapy during the study (for example: moderate to severe asthma)
• Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, pulmonary, cardiac, neurologic, ophthalmologic, or cerebral disease.
• Unwillingness or inability to undergo screening based on current local or country guidelines/standards to evaluate the presence of cancer
• Cancer within the last 5 years
• Current malignancy or signs of possible malignancy detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded
• At risk for or history (within 3 years) of tuberculosis
• Any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis, and bronchiectasis)
• Evidence of active or latent bacterial or viral infection infections at the time of potential enrollment
• Herpes zoster or cytomegalovirus resolving less than 2 months prior to signing informed consent
• Receipt of any live vaccines within 3 months of the anticipated first dose of study medication or anticipation of the need for a live vaccine at any time during and for 3 months after the duration of the study

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (44)

Rheumatology Associates Of North Alabama

Huntsville, Alabama, 35801, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Stanford University School Of Medicine

Palo Alto, California, 94304, United States

Location

Boling Clinical Trials

Upland, California, 91786, United States

Location

Joao Nascimento

Bridgeport, Connecticut, 06606, United States

Location

New England Research Associates, Llc

Trumbull, Connecticut, 06611, United States

Location

Sarasota Arthritis Research Center

Sarasota, Florida, 34239, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01610, United States

Location

Justus Fiechtner, Md, Mph

Lansing, Michigan, 48910, United States

Location

St. Paul Rheumatology P.A.

Eagan, Minnesota, 55121, United States

Location

Midwest Arthritis Center

Kalamazoo, Minnesota, 49048, United States

Location

Arthritis Clinic & Carolina Bone & Joint, Pa

Charlotte, North Carolina, 28210, United States

Location

Deaconess Hospital

Cincinnati, Ohio, 45219, United States

Location

Health Research Of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Rheumatic Disease Associates, Ltd.

Willow Grove, Pennsylvania, 19090, United States

Location

Chase, Walter F.

Austin, Texas, 78705, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98104, United States

Location

Arthritis Northwest

Spokane, Washington, 99204, United States

Location

Local Institution

Capital Federal, Buenos Aires, 1015, Argentina

Location

Local Institution

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution

Santa Fe, Santa Fe Province, 3000, Argentina

Location

Local Institution

Cairns, Queensland, 4872, Australia

Location

Local Institution

Maroochydore, Queensland, 4558, Australia

Location

Local Institution

Fitzroy, Melbourne, Victoria, 3065, Australia

Location

Local Institution

Hasselt, 3500, Belgium

Location

Local Institution

Leuven, 3000, Belgium

Location

Local Institution

St. John's, Newfoundland and Labrador, A1B 3E1, Canada

Location

Local Institution

Montreal, Quebec, H2L 1S6, Canada

Location

Local Institution

Québec, Quebec, G1W 4R4, Canada

Location

Local Institution

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Local Institution

Chambray-lès-Tours, 37170, France

Location

Local Institution

Lille, 59037, France

Location

Local Institution

Montpellier, 34295, France

Location

Local Institution

Frankfurt am Main, 60590, Germany

Location

Local Institution

Hamburg, 22081, Germany

Location

Local Institution

Hildesheim, 31134, Germany

Location

Local Institution

Napoli, 80131, Italy

Location

Local Institution

Potenza, 85100, Italy

Location

Local Institution

Reggio Emilia, 42100, Italy

Location

Local Institution

Amsterdam, 1105 AZ, Netherlands

Location

Local Institution

Lillehammer, 2609, Norway

Location

Local Institution

Panorama, Western Cape, 7500, South Africa

Location

Local Institution

A Coruña, 15006, Spain

Location

Related Publications (2)

• Ostergaard M, Bird P, Pachai C, Du S, Wu C, Landis J, Fuerst T, Ahmad HA, Connolly SE, Conaghan PG. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford). 2022 Nov 2;61(11):4305-4313. doi: 10.1093/rheumatology/keac073.

  PMID: 35137002 DERIVED

• Mease P, Genovese MC, Gladstein G, Kivitz AJ, Ritchlin C, Tak PP, Wollenhaupt J, Bahary O, Becker JC, Kelly S, Sigal L, Teng J, Gladman D. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum. 2011 Apr;63(4):939-48. doi: 10.1002/art.30176.

  PMID: 21128258 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: May 1, 2011
• Last Updated: August 1, 2012
• Results First Posted: November 22, 2010

Record last verified: 2012-07

Locations

ES (1); IT (3); BE (2); AR (3); US (19); FR (3); DE (3); NL (1); NO (1); AU (3); ZA (1); CA (4)