The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis
ASTRAEA=Active PSoriaTic ARthritis RAndomizEd TriAl
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
489
Proportion of ACR 20 Responders at Day 169
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
Proportion of Health Assessment Questionnaire (HAQ) Responders at Day 169
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
Proportion of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation
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.
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Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, United States
Arthritis Asso & Osteo Ctr Of Colorado Springs
Colorado Springs, Colorado, United States
Joao Nascimento
Bridgeport, Connecticut, United States
New England Research Associates, Llc
Trumbull, Connecticut, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Klein And Associates, M.D., Pa
Hagerstown, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States
Box Arthritis And Rheumatology Of The Carolinas, Pllc
Charlotte, North Carolina, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, United States
...and 72 more locations
Time frame: Day 169
Proportion of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation
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
Proportion of Non-progressors in Total PsA-modified SHS at Day 169
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
Proportion of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3%
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
Proportions of ACR 50 and ACR 70 Responders at Day 169
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
Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169
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
Proportion of Participants With at Least One Positive Immunogenicity Response up to Day 169 Relative to Baseline
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
Proportion of Participants With AEs at Day 169
Proportion of participants with AEs at Day 169
Time frame: Day 169
Proportion of Participants With SAEs at Day 169
Proportion of participants with SAEs at Day 169
Time frame: Day 169
Proportion of Participants With AEs Leading to Discontinuation at Day 169
Proportion of participants with AEs leading to discontinuation at Day 169
Time frame: Day 169
Proportion of Participant Deaths at Day 169
Proportion of participant deaths at Day 169
Time frame: Day 169
Proportion of Participants With Marked Laboratory Abnormalities at Day 169
Proportion of participants with marked laboratory abnormalities at Day 169
Time frame: Day 169