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Trial record 1 of 1 for:    IM101-332
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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

Tracking Information
First Submitted Date  ICMJE May 21, 2013
First Posted Date  ICMJE May 23, 2013
Results First Submitted Date  ICMJE July 10, 2017
Results First Posted Date  ICMJE August 2, 2017
Last Update Posted Date August 30, 2017
Actual Study Start Date  ICMJE June 5, 2013
Actual Primary Completion Date July 14, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Percentage of ACR 20 Responders at Day 169 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
Proportion of ACR20 responders [ Time Frame: Day 169 ]
ACR20=20% American College of Rheumatology response
Change History Complete list of historical versions of study NCT01860976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • Percentage of Health Assessment Questionnaire (HAQ) Responders at Day 169 [ Time Frame: Baseline to 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.
  • Percentage of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation [ Time Frame: Day 169 ]
    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.
  • Percentage of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation [ Time Frame: Day 169 ]
    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.
  • Percentage of Non-progressors in Total PsA-modified SHS at Day 169 [ Time Frame: Baseline to 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.
  • Percentage of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3% [ Time Frame: Baseline to Day 169 ]
    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.
  • Percentage of ACR 50 and ACR 70 Responders at Day 169 [ Time Frame: 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.
  • Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169 [ Time Frame: Baseline to 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.
  • Percentage of Participants With at Least One Positive Immunogenicity Response up to Day 169 Relative to Baseline [ Time Frame: Baseline to Day 169 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
  • Proportion of Health Assessment Questionnaire (HAQ) responders (a reduction of at least 0.35 from baseline) [ Time Frame: Baseline (Day 1) and Day 169 ]
  • Proportion of ACR20 responders in the TNFi naive subpopulation [ Time Frame: Day 169 ]
    TNFi=Tumor necrosis factor-α inhibitors
  • Proportion of ACR20 responders in the TNFi exposed subpopulation [ Time Frame: Day 169 ]
  • Proportion of non-progressors in total PsA-modified SHS (defined as a change from baseline in total PsA-modified SHS ≤0) [ Time Frame: Baseline (Day 1) and Day 169 ]
    PsA=Psoriatic arthritis SHS=Sharp/van der Heidje Score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 21, 2013)
  • Proportion of subjects achieving a PASI50 (achieving at least 50% improvement from baseline in PASI) in subjects with baseline BSA ≥3% [ Time Frame: Baseline (Day 1) and Day 169 ]
    PASI=Psoriasis Area and Severity Index BSA=Body Surface Area
  • Proportion of ACR50 responders [ Time Frame: Day 169 ]
  • Proportion of ACR70 responders [ Time Frame: Day 169 ]
  • Mean change from baseline in physical (PCS) and mental functions (MCS) of SF-36 [ Time Frame: Baseline (Day 1) and Day 169 ]
    PCS=Physical Component Score MCS=Mental Component Score SF-36=Short Form 36
  • Proportion of subjects with at least one positive immunogenicity response [ Time Frame: Up to Day 169 ]
  • Proportion of subjects with adverse events (AEs), deaths, serious AEs, and AEs leading to discontinuation and proportion of laboratory marked abnormalities [ Time Frame: Up to Day 169 ]
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis
Official Title  ICMJE A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis
Brief Summary The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis
Detailed Description ASTRAEA=Active PSoriaTic ARthritis RAndomizEd TriAl
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Drug: Abatacept
    Other Name: Orencia
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Abatacept
    Abatacept 125 mg/syringe (125 mg/mL) solution subcutaneously once a week for 168 days double blind/197 days open label/365 days long term extension
    Intervention: Drug: Abatacept
  • Placebo Comparator: Placebo
    Placebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 10, 2017)
489
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2013)
400
Estimated Study Completion Date  ICMJE July 6, 2020
Actual Primary Completion Date July 14, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects at least 18 years of age who have a diagnosis of PsA by Classification Criteria for Psoriatic Arthritis (CASPAR)
  • Subjects have active PsA as shown by a minimum of ≥3 swollen joints and ≥3 tender joints (66/68 joint counts) at screening and randomization/Day 1 (prior to study drug administration). At least one of the swollen joints must be in the digit of the hand or foot
  • Subjects with at least one confirmed ≥2 cm target lesion of plaque psoriasis in a region of the body that can be evaluated excluding the axilla, genitals, groin, palms, and soles
  • Subjects must have had an inadequate response or intolerance to at least one non-biologic disease-modifying anti-rheumatic drug (DMARD)
  • Subjects may have been exposed to TNFi therapy. Subjects may have discontinued for any reason (inadequate response, intolerance or other)
  • Subjects may enroll on certain concomitant non-biologic DMARDs (Methotrexate, Leflunomide, Sulfasalazine, or Hydroxychloroquine) provided the medication has been used for at least 3 months with a stable dose for at least 28 days prior to randomization (Day 1)
  • If using oral corticosteroids (≤10 mg mg/day Prednisone equivalent), dose must be stable ≥14 days prior to randomization (Day 1)
  • Subjects may enroll on systemic retinoids (eg: Acitretin) provided the medication has been used for at least 3 months with a stable dose for at least 28 days prior to randomization (Day 1)

Exclusion Criteria:

  • Subjects with guttate, pustular, or erythrodermic psoriasis
  • Subjects who have had prior exposure to Abatacept (CTLA 4Ig) or other CTLA4 therapies
  • Subjects who have been exposed to any investigational drug within 4 weeks or 5 half lives, whichever is longer
  • Female subjects who had a breast cancer screening study that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations
  • Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. Subjects with carcinoma in situ, treated with definitive surgical intervention prior to study enrollment are allowed
  • Subjects with any bacterial infection within the last 60 days prior to screening (enrollment), unless treated and resolved with antibiotics, or any chronic bacterial infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis)
  • Subjects at risk for tuberculosis (TB). Specifically, subjects with:

    • Current clinical, radiographic or laboratory evidence of active TB
    • A history of active TB within the last 3 years even if it was treated
    • A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type
    • Latent TB which was not successfully treated
    • Subjects with a positive TB screening test indicative of latent TB will not be eligible for the study unless they have no evidence of current TB on chest x-ray at screening and they are actively being treated for TB with isoniazid (INH) or other therapy for latent TB given according to local health authority guidelines (eg: Center for Disease Control). Treatment must have been given for at least 4 weeks prior to randomization (Day 1). These subjects should complete treatment according to local health authority guidelines
  • Subjects with herpes zoster that resolved less than 2 months prior to enrollment
  • Subjects with evidence (as measured by the investigator) of active or latent bacterial, active viral, or serious latent viral infections at the time of enrollment, including subjects with evidence of Immunodeficiency Virus (HIV) infection
  • Subjects who are not currently treated with a non-biologic DMARD and have clinical or radiographic evidence of arthritis mutilans (eg: digital telescoping or "pencil-in-cup" radiographic changes)
  • Subjects who have failed more than 2 TNFi due to inefficacy defined as inadequate response after 3 months treatment at a therapeutic dose
  • Subjects who have received TNFi therapy within 4 weeks for etanercept or within 8 weeks for adalimumab, certolizumab, infliximab, or golimumab
  • Subjects who have received prior use of apremilast within 4 weeks, ustekinumab within 20 weeks or briakinumab within 8 weeks
  • Subjects who have discontinued a non-biologic DMARD or systemic retinoid within four weeks or five half-lives, whichever is longer, prior to randomization (Day 1)
  • Use of any of the following within 28 days or five half lives whichever is longer prior to randomization (Day 1): Cyclosporine A, oral Tacrolimus, Mycophenolate Mofetil (MMF), Hydroxyurea, Fumaric Acid Esters, Paclitaxel, 6-Thioguanine, 6-Mercaptopurine, or Tofacitinib
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Chile,   Colombia,   Czechia,   France,   Germany,   Greece,   Israel,   Italy,   Mexico,   Peru,   Poland,   South Africa,   Spain,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01860976
Other Study ID Numbers  ICMJE IM101-332
2012-002798-80 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP