Safety and Efficacy of Abatacept Versus Placebo in Subjects With Psoriatic Arthritis - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00534313

Purpose

The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of patients with active arthritis due to psoriatic arthritis who have had a prior inadequate response to DMARDs, including (but not limited to) methotrexate and TNF(alpha) blockade compounds.

Condition	Intervention	Phase
Psoriatic Arthritis	Drug: Abatacept Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis

Resource links provided by NLM:

Drug Information available for: Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Primary outcome measure is response of arthritis, as measured by ACR20 response rate [ Time Frame: every month, 6 months double-blind ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response of the psoriatic skin lesions, as measured by Investigators' Global Assessment (IGA) [ Time Frame: every month ] [ Designated as safety issue: No ]
HAQ [ Time Frame: every month ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: every month ] [ Designated as safety issue: No ]
Response of psoriatic Target lesion [ Time Frame: every month ] [ Designated as safety issue: No ]
Proportion with ACR20, ACR50, ACR70, ACR 90 responses [ Time Frame: at Days 365 and 729 ] [ Designated as safety issue: No ]
Proportion with IGA score of clear or almost clear [ Time Frame: at Days 365 and 729 ] [ Designated as safety issue: No ]
Mean percentage change from baseline in target lesion [ Time Frame: at Days 365 and 729 ] [ Designated as safety issue: No ]
Mean changes from baseline in physical and mental summary functions of SF-36 [ Time Frame: at Days 365 and 729 ] [ Designated as safety issue: No ]

Enrollment:	170
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Abatacept (A1): Active Comparator Short Term/Double Blind Period 3 mg/kg calculated dose using the subject's body weight at screening All arms (A1-A4): Open Label - Active study drug (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, LT = 18 months)	Drug: Abatacept solution, intravenous, monthly, ST = 24 wks
Abatacept (A2): Active Comparator 10 mg/kg (fixed dose, based on subject's body weight at screening) 500 mg for subjects weighing < 60kg 750 mg for subjects weighing 60 to 100 kg and 1 gram for subjects weighing > 100 kg	Drug: Abatacept solution, intravenous, monthly, ST = 24 wks
Abatacept (A3): Active Comparator 30 mg/kg (calculated dose using a subject's body weight at screening) on Days 1 and 15, followed by 10 mg/kg (fixed dose, based on subject's body weight at screening 500 mg for subjects weighing < 60kg 750 mg for subjects weighing 60 to 100 kg and 1 gram for subjects weighing > 100 kg	Drug: Abatacept solution, intravenous, monthly, ST = 24 wks
Placebo (A4): Placebo Comparator	Drug: placebo solution, intravenous, placebo (double dummy), monthly, ST = 24 wks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of psoriatic arthritis
Active arthritis
Active psoriasis
Prior failure of DMARD therapy (methotrexate, TNF blockade or other)
For women of child bearing potential-must use appropriate birth control

Exclusion Criteria:

Drug or alcohol abuse
Severe uncontrolled underlying medical conditions
Cancer within the last 5 years
Unable/ unwilling to undergo locally prescribed routine cancer screening
At risk for contracting TB
Evidence of active or latent bacterial or viral infection
Recent significant bacterial infection within 3 months of the anticipated first dose
Live vaccine within 3 months of the anticipated first dose

LT/Open-Label: Must have met eligibility criteria for ST and completed ST/Double-Blind (24-week) phase of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534313

Show 44 Study Locations

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

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-158, EUDRACT 2007-004241-15
Study First Received:	September 20, 2007
Last Updated:	September 28, 2009
ClinicalTrials.gov Identifier:	NCT00534313 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Spinal Diseases
Immunologic Factors
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Bone Diseases
Pharmacologic Actions

Abatacept
Musculoskeletal Diseases
Psoriasis
Therapeutic Uses
Arthritis
Antirheumatic Agents
Spondylarthritis
Skin Diseases, Papulosquamous
Spondylarthropathies

ClinicalTrials.gov processed this record on November 30, 2009