Psoriatic ArthritisPhase 3ASTRAEANCT01860976
Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis
A Phase 3 study testing Abatacept in people with Psoriatic Arthritis, run by Bristol-Myers Squibb at 82 sites in 17 countries.
Trial summary
The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 489 participants
- Where
- 82 sitesin 17 countries
- Study dates
- 17 Jun 2013to 30 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 20Show fewer
- 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-Mercatopurine, or Tofacitinib
Trial locations and contacts
82 sites in 17 countries.
82 sites in 17 countries
United States17 sites
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, 18015
Tufts Medical Center
Boston, Massachusetts, 02111
Joao Nascimento
Bridgeport, Connecticut, 06606
Box Arthritis And Rheumatology Of The Carolinas, Pllc
Charlotte, North Carolina, 28210
Arthritis Asso & Osteo Ctr Of Colorado Springs
Colorado Springs, Colorado, 80920
St. Paul Rheumatology, P.A.
Eagan, Minnesota, 55121
Klein And Associates, M.D., Pa
Hagerstown, Maryland, 21740
West Tennessee Research Institute
Jackson, Tennessee, 38305
Rheumatology Consultants Pllc
Knoxville, Tennessee, 37909-1907
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, 44130
Health Research Of Oklahoma
Oklahoma City, Oklahoma, 73103
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, 85037
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
Seattle Rheumatology Associates
Seattle, Washington, 98122
Arthritis Northwest
Spokane, Washington, 99204
New England Research Associates, Llc
Trumbull, Connecticut, 06611
Clinical Research Center Of Reading, Llc
Wyomissing, Pennsylvania, 19610
Germany7 sites
Local Institution
Bad Abbach, 93077
Local Institution
Erlangen, 91054
Local Institution
Freiburg im Breisgau, 79106
Local Institution
Hamburg, 22081
Local Institution
München, 80336
Local Institution
Ratingen, 40878
Local Institution
Trier, 54292
Mexico7 sites
Local Institution
Aguascalientes, 20127
Local Institution
Guadalajara, Jalisco, 44650
Local Institution
Mérida, Yucatán, 97000
Local Institution
Mérida, Yucatán, 97070
Local Institution
Mexico City, Mexico City, 06090
Local Institution
Monterrey, N.l., Nuevo León, 64460
Local Institution
Zapopan, Jalisco, 45190
Argentina6 sites
Instituto De Rehabilitacion Psicofisica
Buenos Aires, 1428
Local Institution
Ciudad Autonoma Beunos Aires, Buenos Aires, 1431
Instituto Reumatologico Strusberg
Córdoba, 5000
Caici
Rosario, Santa Fe Province, 2000
Instituto de Asistencia Reumatologica Integral
San Fernando, Buenos Aires, 1646
Centro Medico Privado De Reumatologia
San Miguel de Tucumán, Tucumán Province, 4000
France5 sites
Local Institution
Chambray-lès-Tours, 37170
Local Institution
Lille, 59037
Local Institution
Montpellier, 34295
Local Institution
Poitiers, 86021
Local Institution
Strasbourg, 67098
South Africa5 sites
Local Institution
Cape Town, Western Cape, 7500
Local Institution
Pinelands, Cape Town, Western Cape, 7405
Local Institution
Pretoria, Gauteng, 0002
Local Institution
Pretoria, Gauteng, 0084
Local Institution
Stellenbosch, Western Cape, 7600
Canada4 sites
Groupe De Recherche En Rhumatologie Et Maladies Osseuses
Québec, Quebec, G1V 3M7
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
Manna Research
Toronto, Ontario, M9W 4L6
Israel4 sites
Local Institution
Ashkelon, 78278
Local Institution
Haifa, 34362
Local Institution
Ramat Gan, 52621
Local Institution
Tel Aviv, 64239
Italy4 sites
Local Institution
Florence, 50139
Local Institution
Milan, 20122
Local Institution
Palermo
Local Institution
Viale Europa Cantanzaro, 88100
Poland4 sites
Local Institution
Dąbrówka, 62-069
Local Institution
Elblag, Warminsko-mazurski, 82-300
Local Institution
Mysłowice, 41-400
Local Institution
Warsaw, 01-518
Chile3 sites
Local Institution
Santiago, Santiago Metropolitan, 0
Local Institution
Santiago, 7500010
Local Institution
Viña del Mar, Valparaiso, 2520997
Colombia3 sites
Riesgo De Fractura
Bogota, Cundinamarca
Servimed E.U
Bucaramanga
Clinica de Artritis Temprana
Cali
Czechia3 sites
Local Institution
Prague, 128 50
Local Institution
Prague, 140 00
Local Institution
Prague, 148 00
Peru3 sites
Clinica San Felipe
Lima, LIMA 11
Hospital Nacional Guillermo Almenara Irigoyen
Lima, LIMA 13
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
Lima, LIMA 33
Spain3 sites
Local Institution
A Coruña, 15006
Local Institution
Santander, 39008
Local Institution
Seville, 41009
Brazil2 sites
Local Institution
Curitiba, Paraná, 80440-080
Local Institution
Juiz de Fora, Minas Gerais, 36010-570
About this study
Official title: A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis
The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis
Read the detailed description
ASTRAEA=Active PSoriaTic ARthritis RAndomizEd TriAl
- Conditions
- Psoriatic Arthritis
- Being tested
- Abatacept, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | 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 Receives: Drug: Abatacept |
| Placebo | Placebo comparator | Placebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 169
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 169
Proportion of Participants With AEs at Day 169
Proportion of participants with AEs at Day 169
Measured: Day 169
Proportion of Participants With SAEs at Day 169
Proportion of participants with SAEs at Day 169
Measured: Day 169
Proportion of Participants With AEs Leading to Discontinuation at Day 169
Proportion of participants with AEs leading to discontinuation at Day 169
Measured: Day 169
Proportion of Participant Deaths at Day 169
Proportion of participant deaths at Day 169
Measured: Day 169
Proportion of Participants With Marked Laboratory Abnormalities at Day 169
Proportion of participants with marked laboratory abnormalities at Day 169
Measured: Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study start17 Jun 2013
- Primary completion14 Jul 2015
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860976
- Sponsor's protocol ID
- IM101-332
- Other IDs
- 2012-002798-80
- Acronym
- ASTRAEA
- Status last verified
- Mar 2022
- First submitted
- 21 May 2013
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McInnes IB, Ferraccioli G, D'Agostino MA, Le Bars M, Banerjee S, Ahmad HA, Elbez Y, Mease PJ. Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial. RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.
PubMed 31245054Strand V, Alemao E, Lehman T, Johnsen A, Banerjee S, Ahmad HA, Mease PJ. Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial. Arthritis Res Ther. 2018 Dec 6;20(1):269. doi: 10.1186/s13075-018-1769-7.
PubMed 30522501Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017 Sep;76(9):1550-1558. doi: 10.1136/annrheumdis-2016-210724. Epub 2017 May 4.
PubMed 28473423
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT01860976
- Acronym / sponsor ID
- ASTRAEA / IM101-332
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2013 (actual)
- Primary completion
- 14 Jul 2015 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 May 2013 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Drug: AbataceptAbatacept 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 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: Orencia | Drug | Abatacept |
| Placebo | Drug | Placebo |
Primary outcome
Proportion 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.
13 secondary outcomes
Proportion of Health Assessment Questionnaire (HAQ) Responders at Day 169
Time frame: Baseline to Day 169
Proportion of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation
Time frame: Day 169
Proportion of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation
Time frame: Day 169
Proportion of Non-progressors in Total PsA-modified SHS at Day 169
Time frame: Baseline to Day 169
Proportion of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3%
Time frame: Baseline to Day 169
Proportions of ACR 50 and ACR 70 Responders at Day 169
Time frame: Day 169
Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169
Time frame: Baseline to Day 169
Proportion of Participants With at Least One Positive Immunogenicity Response up to Day 169 Relative to Baseline
Time frame: Baseline to Day 169
Proportion of Participants With AEs at Day 169
Time frame: 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
Time frame: Day 169
Proportion of Participant Deaths at Day 169
Time frame: Day 169
Proportion of Participants With Marked Laboratory Abnormalities at Day 169
Time frame: Day 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31245054McInnes IB, Ferraccioli G, D'Agostino MA, Le Bars M, Banerjee S, Ahmad HA, Elbez Y, Mease PJ. Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial. RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.
- Derived from this study: PubMed 30522501Strand V, Alemao E, Lehman T, Johnsen A, Banerjee S, Ahmad HA, Mease PJ. Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial. Arthritis Res Ther. 2018 Dec 6;20(1):269. doi: 10.1186/s13075-018-1769-7.
- Derived from this study: PubMed 28473423Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017 Sep;76(9):1550-1558. doi: 10.1136/annrheumdis-2016-210724. Epub 2017 May 4.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
82 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abatacept in people with Psoriatic Arthritis, run by Bristol-Myers Squibb at 82 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Germany, Mexico, Argentina, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ACR 20 Responders at Day 169 (time frame: Day 169). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01860976, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.