Back to resultsSafety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
Primary Purpose
Psoriatic Arthritis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Abatacept
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
Eligibility Criteria
Key Inclusion Criteria:
- 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)
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
Sites / Locations
- Rheumatology Associates Of North Alabama
- Desert Medical Advances
- Stanford University School Of Medicine
- Boling Clinical Trials
- Joao Nascimento
- New England Research Associates, Llc
- Sarasota Arthritis Research Center
- Clinical Pharmacology Study Group
- Justus Fiechtner, Md, Mph
- St. Paul Rheumatology P.A.
- Midwest Arthritis Center
- Arthritis Clinic & Carolina Bone & Joint, Pa
- Deaconess Hospital
- Health Research Of Oklahoma
- Altoona Center For Clinical Research
- Rheumatic Disease Associates, Ltd.
- Chase, Walter F.
- Seattle Rheumatology Associates
- Arthritis Northwest
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Abatacept (30/10)
Abatacept (10/10)
Abatacept (3/3)
Placebo
Arm Description
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.
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).
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 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.
Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729
IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729
Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
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
PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
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
Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.
Short-term Period: Number of Participants With Marked Abnormalities in Hematology
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN.
Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL.
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry
ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx.
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or <LLN.
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value.
Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis
Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4).
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
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169
Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169
Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)
Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody].
Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169
PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Short-term Period: Mean Serum Concentrations of Abatacept
Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.
Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept
Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.
Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters
PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.
Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169
PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00534313
Brief Title
Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy with respect to skin-related lesions in the short-term phase
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abatacept (30/10)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Abatacept (10/10)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Abatacept (3/3)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia, BMS-188667
Intervention Description
Solution, intravenous, monthly, short-term = 24 weeks (6 months)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From Day 169 to Day 729
Title
Short-term Period: Number of Participants With ACR 20 Response at Day 169
Description
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.
Time Frame
At Day 169 from Baseline
Secondary Outcome Measure Information:
Title
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
Description
An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.
Time Frame
At Days 365 and 729 from Baseline
Title
Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729
Description
IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
Time Frame
From Day 169 to Days 365 and 729
Title
Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729
Description
Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
Time Frame
From Baseline to Days 365 and 729
Title
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
Description
PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Time Frame
At Days 365 and 729 from baseline
Title
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
Description
Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.
Time Frame
Days 365 and 729 from baseline
Title
Short-term Period: Number of Participants With Marked Abnormalities in Hematology
Description
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN.
Time Frame
From Baseline to Day 169
Title
Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)
Description
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL.
Time Frame
From Baseline to Day 169
Title
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry
Description
ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx.
Time Frame
Baseline to Day 169
Title
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
Description
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or <LLN.
Time Frame
Baseline to Day 169
Title
Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
Description
LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value.
Time Frame
From Baseline to Day 169
Title
Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis
Description
Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4).
Time Frame
From Baseline to Day 169
Title
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
Description
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Time Frame
From Baseline to Day 169
Title
Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169
Description
Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
Time Frame
At Day 169 from Baseline
Title
Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169
Description
Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
Time Frame
At Day 169 from Baseline
Title
Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)
Description
Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody].
Time Frame
From Baseline to Day 169
Title
Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169
Description
PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Time Frame
At Day 169 from Baseline
Title
Short-term Period: Mean Serum Concentrations of Abatacept
Description
Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.
Time Frame
Days 1, 15, 29, 57, 85, 113, 141, and 169
Title
Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept
Description
Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.
Time Frame
Days 1, 15, 29, 57, 85, 113, 141, and 169
Title
Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters
Description
PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.
Time Frame
Days 1, 15, 29, 57, 85, 113, 141, and 169
Title
Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169
Description
PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Time Frame
At Day 169 from Baseline
Title
Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
Description
The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.
Time Frame
At Day 169 from Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Associates Of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Stanford University School Of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Boling Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Joao Nascimento
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
New England Research Associates, Llc
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Sarasota Arthritis Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Justus Fiechtner, Md, Mph
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
St. Paul Rheumatology P.A.
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Midwest Arthritis Center
City
Kalamazoo
State/Province
Minnesota
ZIP/Postal Code
49048
Country
United States
Facility Name
Arthritis Clinic & Carolina Bone & Joint, Pa
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Deaconess Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Health Research Of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Rheumatic Disease Associates, Ltd.
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Chase, Walter F.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Seattle Rheumatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Arthritis Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1015
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Local Institution
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4872
Country
Australia
Facility Name
Local Institution
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Local Institution
City
Fitzroy, Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Local Institution
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
St. John'S
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Local Institution
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Local Institution
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Local Institution
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Local Institution
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Local Institution
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Local Institution
City
Lillehammer
ZIP/Postal Code
2609
Country
Norway
Facility Name
Local Institution
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
35137002
Citation
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.
Results Reference
derived
PubMed Identifier
21128258
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
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