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Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis (ASTRAEA)

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ClinicalTrials.gov Identifier: NCT01860976
Recruitment Status : Active, not recruiting
First Posted : May 23, 2013
Results First Posted : August 2, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: Abatacept
Drug: Placebo
Enrollment 489
Recruitment Details  
Pre-assignment Details 489 were enrolled in the study. 424 were randomized to a treatment group and received at least one dose of blinded study drug. Reasons for non-randomization were no longer met criteria (n=45), withdrawal of consent (n=15), non-compliance (n=2), adverse event (n=1), lost to follow-up (n=1), or other reasons (n=1)
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description Abatacept 125mg, self-administered subcutaneously, once weekly Placebo, self-administered subcutaneously, once weekly.
Period Title: Blinded Treatment
Started 213 211
Completed 125 98
Not Completed 88 113
Reason Not Completed
Adverse Event             1             3
Lack of Efficacy             5             12
Subject request to discontinue treatment             2             3
Withdrawal by Subject             3             5
Subject no longer met criteria             1             0
Entered Open-Label in error             0             1
Early Escape: Transitioned to OL period             76             89
Period Title: Open-Label
Started 197 185
Completed 123 121
Not Completed 74 64
Reason Not Completed
Adverse Event             2             4
Lack of Efficacy             16             8
Lost to Follow-up             1             2
Subject request discontinue treatment             4             3
Withdrawal by Subject             4             1
Other Reasons             1             1
Ongoing OL treatment at time of analysis             46             45
Period Title: Long Term Extension
Started 113 115
Completed 0 8
Not Completed 113 107
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             3             7
Subject request to discontinue treatment             2             0
Withdrawal by Subject             1             0
Ongoing treatment at time of analysis             106             100
Arm/Group Title Abatacept Placebo Total
Hide Arm/Group Description Abatacept 125mg, self-administered subcutaneously, once weekly Placebo, self-administered subcutaneously, once weekly. Total of all reporting groups
Overall Number of Baseline Participants 213 211 424
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 213 participants 211 participants 424 participants
51.0  (10.67) 49.8  (11.26) 50.4  (10.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 211 participants 424 participants
Female
121
  56.8%
112
  53.1%
233
  55.0%
Male
92
  43.2%
99
  46.9%
191
  45.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 213 participants 211 participants 424 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   0.5%
1
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
195
  91.5%
198
  93.8%
393
  92.7%
More than one race
18
   8.5%
11
   5.2%
29
   6.8%
Unknown or Not Reported
0
   0.0%
1
   0.5%
1
   0.2%
1.Primary Outcome
Title Percentage of ACR 20 Responders at Day 169
Hide Description The American College of Rheumatology (ACR) 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 213 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
39.4
(32.9 to 46.0)
22.3
(16.7 to 27.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of Difference
Estimated Value 17.2
Confidence Interval (2-Sided) 95%
8.7 to 25.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Health Assessment Questionnaire (HAQ) Responders at Day 169
Hide Description Participants were considered responders if their HAQ score decreased at least 0.35 from baseline. The number of HAQ responders was divided by the number of treated participants and expressed as a percentage. Scoring conventions are based on the Standard Disability Index of HAQ/HAQ-DI using the 20 response items. For each of the 8 disability categories there is an “aids/devices” companion variable that is used to record the type of assistance, if any, a participant uses for his/her usual activities. If either “aids/devices” and/or “assistance from another person” are checked for a disability category, the score for this category is set to “2” (much difficulty), if the original score was “0” (no difficulty) or “1” (some difficulty). The HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 213 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.0
(24.8 to 37.2)
23.7
(18.0 to 29.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 7.2
Confidence Interval (2-Sided) 95%
-1.1 to 15.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation
Hide Description The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-naive participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated TNFi-naïve participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 84 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
44.0
(33.4 to 54.7)
22.2
(13.2 to 31.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 21.9
Confidence Interval (2-Sided) 95%
8.3 to 35.6
Estimation Comments Because the treatment difference for HAQ response rate was not significant at the 5% significance level, nominal p values are presented for endpoints lower in the testing hierarchy.
4.Secondary Outcome
Title Percentage of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation
Hide Description The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-exposed participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated TNFi-exposed participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 129 130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
36.4
(28.1 to 44.7)
22.3
(15.2 to 29.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 14.0
Confidence Interval (2-Sided) 95%
3.3 to 24.8
Estimation Comments Because the treatment difference for HAQ response rate was not significant at the 5% significance level, nominal p values are presented for endpoints lower in the testing hierarchy.
5.Secondary Outcome
Title Percentage of Non-progressors in Total PsA-modified SHS at Day 169
Hide Description The number of radiographic non-progressors in total PsA-Modified Sharp van der Heijde score (SHS) at Day 169 was divided by the number of treated participants and expressed as a percentage. Non-progression was defined as a change from baseline in total PsA modified SHS ≤0. Early escape participants, and participants with missing data at day 169 were imputed as non-progressors.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 213 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
42.7
(36.1 to 49.4)
32.7
(26.4 to 39.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
1.0 to 19.1
Estimation Comments Because the treatment difference for HAQ response rate was not significant at the 5% significance level, nominal p values are presented for endpoints lower in the testing hierarchy.
6.Secondary Outcome
Title Percentage of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3%
Hide Description The number of participants who achieved at least 50% improvement from baseline in Psoriasis Area and Severity Index Arthritis (PASI 50) at Day 169 was divided by the number of treated participants with BSA >= 3% and expressed as a percentage. Only participants with >= 3% body surface area (BSA) of psoriatic skin involvement at randomization were included in this analysis.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with >= 3% BSA of psoriatic skin involvement at randomization
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 146 148
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
26.7
(19.5 to 33.9)
19.6
(13.2 to 26.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
-2.2 to 16.7
Estimation Comments Because the treatment difference for HAQ response rate was not significant at the 5% significance level, nominal p values are presented for endpoints lower in the testing hierarchy.
7.Secondary Outcome
Title Percentage of ACR 50 and ACR 70 Responders at Day 169
Hide Description The ACR 50 and ACR 70 definition of improvement is a 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 50% or 70% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 50 and ACR 70 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 213 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
ACR 50
19.2
(14.0 to 24.5)
12.3
(7.9 to 16.8)
ACR 70
10.3
(6.2 to 14.4)
6.6
(3.3 to 10.0)
8.Secondary Outcome
Title Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169
Hide Description Adjusted mean change in scores on the Short Form 36 physical and mental function assessment (SF-36) from baseline were analyzed from the physical component summary (PCS) mental component summary (MCS). The SF-36 is a participant questionnaire assessing 8 domains of health status: physical functioning, pain, vitality, social functioning, psychological functioning, general health perception, and role limitations due to physical and emotional problems. The instrument can be divided into two summary scores, physical and mental component score. The scores range from 0 to 100, with a higher score indicating better quality of life. The two summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 213 211
Mean (Standard Error)
Unit of Measure: units on a scale
PCS 5.11  (0.637) 3.69  (0.707)
MCS 2.56  (0.826) 2.62  (0.924)
9.Secondary Outcome
Title Percentage of Participants With at Least One Positive Immunogenicity Response up to Day 169 Relative to Baseline
Hide Description Blood samples were collected at Days 1, 85 and 169 and assayed for the presence of abatacept-specific antibodies. The number of participants with at least one positive immunogenicity response was divided by the number of treated participants and expressed as a percentage.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Abatacept 125mg, self-administered subcutaneously, once weekly
Placebo, self-administered subcutaneously, once weekly.
Overall Number of Participants Analyzed 203 198
Measure Type: Number
Unit of Measure: Percentage of participants
3.9 8.6
Time Frame Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SC ABATACEPT PLACEBO
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
SC ABATACEPT PLACEBO
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SC ABATACEPT PLACEBO
Affected / at Risk (%) Affected / at Risk (%)
Total   6/213 (2.82%)   9/211 (4.27%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/213 (0.00%)  1/211 (0.47%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/213 (0.00%)  1/211 (0.47%) 
Immune system disorders     
Anaphylactic reaction  1  0/213 (0.00%)  1/211 (0.47%) 
Infections and infestations     
Appendicitis  1  0/213 (0.00%)  1/211 (0.47%) 
Cellulitis  1  0/213 (0.00%)  1/211 (0.47%) 
Gastroenteritis  1  2/213 (0.94%)  0/211 (0.00%) 
Pneumocystis jirovecii infection  1  1/213 (0.47%)  0/211 (0.00%) 
Injury, poisoning and procedural complications     
Vascular pseudoaneurysm  1  0/213 (0.00%)  1/211 (0.47%) 
Investigations     
Alanine aminotransferase increased  1  0/213 (0.00%)  1/211 (0.47%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/213 (0.47%)  0/211 (0.00%) 
Psoriatic arthropathy  1  0/213 (0.00%)  1/211 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma  1  0/213 (0.00%)  1/211 (0.47%) 
Invasive ductal breast carcinoma  1  0/213 (0.00%)  1/211 (0.47%) 
Respiratory, thoracic and mediastinal disorders     
Acute chest syndrome  1  0/213 (0.00%)  1/211 (0.47%) 
Interstitial lung disease  1  1/213 (0.47%)  0/211 (0.00%) 
Pulmonary embolism  1  1/213 (0.47%)  0/211 (0.00%) 
Vascular disorders     
Peripheral artery thrombosis  1  0/213 (0.00%)  1/211 (0.47%) 
Venous thrombosis  1  1/213 (0.47%)  0/211 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SC ABATACEPT PLACEBO
Affected / at Risk (%) Affected / at Risk (%)
Total   15/213 (7.04%)   24/211 (11.37%) 
Infections and infestations     
Nasopharyngitis  1  9/213 (4.23%)  11/211 (5.21%) 
Upper respiratory tract infection  1  6/213 (2.82%)  14/211 (6.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01860976     History of Changes
Other Study ID Numbers: IM101-332
2012-002798-80 ( EudraCT Number )
First Submitted: May 21, 2013
First Posted: May 23, 2013
Results First Submitted: July 10, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 30, 2017