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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00534313




Registration number
NCT00534313
Ethics application status
Date submitted
20/09/2007
Date registered
24/09/2007
Date last updated
1/08/2012

Titles & IDs
Public title
Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
Scientific 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
Secondary ID [1] 0 0
EUDRACT 2007-004241-15
Secondary ID [2] 0 0
IM101-158
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - Placebo

Active comparator: Abatacept (30/10) - 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.

Active comparator: Abatacept (10/10) - 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).

Active comparator: Abatacept (3/3) - 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.

Placebo comparator: Placebo - 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.


Treatment: Drugs: Abatacept
Solution, intravenous, monthly, short-term = 24 weeks (6 months)

Treatment: Drugs: Placebo
Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From Day 169 to Day 729
Primary outcome [2] 0 0
Short-term Period: Number of Participants With ACR 20 Response at Day 169
Timepoint [2] 0 0
At Day 169 from Baseline
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
At Days 365 and 729 from Baseline
Secondary outcome [2] 0 0
Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729
Timepoint [2] 0 0
From Day 169 to Days 365 and 729
Secondary outcome [3] 0 0
Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729
Timepoint [3] 0 0
From Baseline to Days 365 and 729
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
At Days 365 and 729 from baseline
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Days 365 and 729 from baseline
Secondary outcome [6] 0 0
Short-term Period: Number of Participants With Marked Abnormalities in Hematology
Timepoint [6] 0 0
From Baseline to Day 169
Secondary outcome [7] 0 0
Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)
Timepoint [7] 0 0
From Baseline to Day 169
Secondary outcome [8] 0 0
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry
Timepoint [8] 0 0
Baseline to Day 169
Secondary outcome [9] 0 0
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
Timepoint [9] 0 0
Baseline to Day 169
Secondary outcome [10] 0 0
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
Timepoint [10] 0 0
From Baseline to Day 169
Secondary outcome [11] 0 0
Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis
Timepoint [11] 0 0
From Baseline to Day 169
Secondary outcome [12] 0 0
Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs
Timepoint [12] 0 0
From Baseline to Day 169
Secondary outcome [13] 0 0
Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169
Timepoint [13] 0 0
At Day 169 from Baseline
Secondary outcome [14] 0 0
Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169
Timepoint [14] 0 0
At Day 169 from Baseline
Secondary outcome [15] 0 0
Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)
Timepoint [15] 0 0
From Baseline to Day 169
Secondary outcome [16] 0 0
Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169
Timepoint [16] 0 0
At Day 169 from Baseline
Secondary outcome [17] 0 0
Short-term Period: Mean Serum Concentrations of Abatacept
Timepoint [17] 0 0
Days 1, 15, 29, 57, 85, 113, 141, and 169
Secondary outcome [18] 0 0
Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept
Timepoint [18] 0 0
Days 1, 15, 29, 57, 85, 113, 141, and 169
Secondary outcome [19] 0 0
Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters
Timepoint [19] 0 0
Days 1, 15, 29, 57, 85, 113, 141, and 169
Secondary outcome [20] 0 0
Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169
Timepoint [20] 0 0
At Day 169 from Baseline
Secondary outcome [21] 0 0
Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
Timepoint [21] 0 0
At Day 169 from Baseline

Eligibility
Key inclusion criteria
Key

* 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 a-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)

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Long-term period participants: Must have met eligibility criteria for short-term period and completed short-term (24-week) period of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - Cairns
Recruitment hospital [2] 0 0
Local Institution - Maroochydore
Recruitment hospital [3] 0 0
Local Institution - Fitzroy, Melbourne
Recruitment postcode(s) [1] 0 0
4872 - Cairns
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy, Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Belgium
State/province [16] 0 0
Hasselt
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Canada
State/province [18] 0 0
Newfoundland and Labrador
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
France
State/province [20] 0 0
Chambray Les Tours
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Montpellier Cedex 5
Country [23] 0 0
Germany
State/province [23] 0 0
Frankfurt/Main
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hildesheim
Country [26] 0 0
Italy
State/province [26] 0 0
Napoli
Country [27] 0 0
Italy
State/province [27] 0 0
Potenza
Country [28] 0 0
Italy
State/province [28] 0 0
Reggio Emilia
Country [29] 0 0
Netherlands
State/province [29] 0 0
Amsterdam
Country [30] 0 0
Norway
State/province [30] 0 0
Lillehammer
Country [31] 0 0
South Africa
State/province [31] 0 0
Western Cape
Country [32] 0 0
Spain
State/province [32] 0 0
A Coruna

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00534313