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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002798-80 | EudraCT Number |
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The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis
ASTRAEA=Active PSoriaTic ARthritis RAndomizEd TriAl
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Placebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Research PLLC | Phoenix | Arizona | 85037 | United States | ||
| Arthritis Asso & Osteo Ctr Of Colorado Springs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31245054 | Derived | 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. | |
| 30522501 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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424 were Randomized and Treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Abatacept | Abatacept 125mg, self-administered subcutaneously, once weekly |
| FG001 | Placebo | Placebo, self-administered subcutaneously, once weekly. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded Treatment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2014 |
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| Drug |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to Day 169 |
| Proportion of Participants With AEs at Day 169 | Proportion of participants with AEs at Day 169 | Day 169 |
| Proportion of Participants With SAEs at Day 169 | Proportion of participants with SAEs at Day 169 | Day 169 |
| Proportion of Participants With AEs Leading to Discontinuation at Day 169 | Proportion of participants with AEs leading to discontinuation at Day 169 | Day 169 |
| Proportion of Participant Deaths at Day 169 | Proportion of participant deaths at Day 169 | Day 169 |
| Proportion of Participants With Marked Laboratory Abnormalities at Day 169 | Proportion of participants with marked laboratory abnormalities at Day 169 | Day 169 |
| Colorado Springs |
| Colorado |
| 80920 |
| United States |
| Joao Nascimento | Bridgeport | Connecticut | 06606 | United States |
| New England Research Associates, Llc | Trumbull | Connecticut | 06611 | United States |
| Sarasota Arthritis Research Center | Sarasota | Florida | 34239 | United States |
| Klein And Associates, M.D., Pa | Hagerstown | Maryland | 21740 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| St. Paul Rheumatology, P.A. | Eagan | Minnesota | 55121 | United States |
| Box Arthritis And Rheumatology Of The Carolinas, Pllc | Charlotte | North Carolina | 28210 | United States |
| Paramount Medical Research & Consulting, Llc | Middleburg Heights | Ohio | 44130 | United States |
| Health Research Of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| East Penn Rheumatology Associates, P.C. | Bethlehem | Pennsylvania | 18015 | United States |
| Clinical Research Center Of Reading, Llc | Wyomissing | Pennsylvania | 19610 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Rheumatology Consultants Pllc | Knoxville | Tennessee | 37909-1907 | United States |
| Seattle Rheumatology Associates | Seattle | Washington | 98122 | United States |
| Arthritis Northwest | Spokane | Washington | 99204 | United States |
| Local Institution | Ciudad Autonoma Beunos Aires | Buenos Aires | 1431 | Argentina |
| Instituto de Asistencia Reumatologica Integral | San Fernando | Buenos Aires | 1646 | Argentina |
| Caici | Rosario | Santa Fe Province | 2000 | Argentina |
| Centro Medico Privado De Reumatologia | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Instituto De Rehabilitacion Psicofisica | Buenos Aires | 1428 | Argentina |
| Instituto Reumatologico Strusberg | Córdoba | 5000 | Argentina |
| Local Institution | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| Local Institution | Curitiba | Paraná | 80440-080 | Brazil |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Toronto Western Hospital, University Health Network | Toronto | Ontario | M5T 2S8 | Canada |
| Manna Research | Toronto | Ontario | M9W 4L6 | Canada |
| Groupe De Recherche En Rhumatologie Et Maladies Osseuses | Québec | Quebec | G1V 3M7 | Canada |
| Local Institution | Santiago | Santiago Metropolitan | 0 | Chile |
| Local Institution | Viña del Mar | Valparaiso | 2520997 | Chile |
| Local Institution | Santiago | 7500010 | Chile |
| Riesgo De Fractura | Bogota | Cundinamarca | Colombia |
| Servimed E.U | Bucaramanga | Colombia |
| Clinica de Artritis Temprana | Cali | Colombia |
| Local Institution | Prague | 128 50 | Czechia |
| Local Institution | Prague | 140 00 | Czechia |
| Local Institution | Prague | 148 00 | Czechia |
| Local Institution | Chambray-lès-Tours | 37170 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Montpellier | 34295 | France |
| Local Institution | Poitiers | 86021 | France |
| Local Institution | Strasbourg | 67098 | France |
| Local Institution | Bad Abbach | 93077 | Germany |
| Local Institution | Erlangen | 91054 | Germany |
| Local Institution | Freiburg im Breisgau | 79106 | Germany |
| Local Institution | Hamburg | 22081 | Germany |
| Local Institution | München | 80336 | Germany |
| Local Institution | Ratingen | 40878 | Germany |
| Local Institution | Trier | 54292 | Germany |
| Local Institution | Athens | 11527 | Greece |
| Local Institution | Crete | 71110 | Greece |
| Local Institution | Ashkelon | 78278 | Israel |
| Local Institution | Haifa | 34362 | Israel |
| Local Institution | Ramat Gan | 52621 | Israel |
| Local Institution | Tel Aviv | 64239 | Israel |
| Local Institution | Florence | 50139 | Italy |
| Local Institution | Milan | 20122 | Italy |
| Local Institution | Palermo | Italy |
| Local Institution | Viale Europa Cantanzaro | 88100 | Italy |
| Local Institution | Guadalajara | Jalisco | 44650 | Mexico |
| Local Institution | Zapopan | Jalisco | 45190 | Mexico |
| Local Institution | Mexico City | Mexico City | 06090 | Mexico |
| Local Institution | Monterrey, N.l. | Nuevo León | 64460 | Mexico |
| Local Institution | Mérida | Yucatán | 97000 | Mexico |
| Local Institution | Mérida | Yucatán | 97070 | Mexico |
| Local Institution | Aguascalientes | 20127 | Mexico |
| Clinica San Felipe | Lima | LIMA 11 | Peru |
| Hospital Nacional Guillermo Almenara Irigoyen | Lima | LIMA 13 | Peru |
| Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac | Lima | LIMA 33 | Peru |
| Local Institution | Elblag | Warminsko-mazurski | 82-300 | Poland |
| Local Institution | Dąbrówka | 62-069 | Poland |
| Local Institution | Mysłowice | 41-400 | Poland |
| Local Institution | Warsaw | 01-518 | Poland |
| Local Institution | Pretoria | Gauteng | 0002 | South Africa |
| Local Institution | Pretoria | Gauteng | 0084 | South Africa |
| Local Institution | Cape Town | Western Cape | 7500 | South Africa |
| Local Institution | Pinelands, Cape Town | Western Cape | 7405 | South Africa |
| Local Institution | Stellenbosch | Western Cape | 7600 | South Africa |
| Local Institution | A Coruña | 15006 | Spain |
| Local Institution | Santander | 39008 | Spain |
| Local Institution | Seville | 41009 | Spain |
| Strand 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. |
| 28473423 | Derived | Mease 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 Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED | completed = participants who completed treatment period |
|
| NOT COMPLETED |
|
|
| Open-Label |
|
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| Long Term Extension |
|
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All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept | Abatacept 125mg, self-administered subcutaneously, once weekly |
| BG001 | Placebo | Placebo, self-administered subcutaneously, once weekly. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 169 |
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| Secondary | 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. | All treated participants | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Day 169 |
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| Secondary | 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. | All treated TNFi-naïve participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 169 |
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| Secondary | 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. | All treated TNFi-exposed participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 169 |
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| Secondary | 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. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Day 169 |
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| Secondary | 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. | All treated participants with >= 3% BSA of psoriatic skin involvement at randomization | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Day 169 |
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| Secondary | 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. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 169 |
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| Secondary | 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. | All treated participants | Posted | Mean | Standard Error | SF-36 points | Baseline to Day 169 |
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| Secondary | 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. | All treated participants | Posted | Number | Percentage of participants | Baseline to Day 169 |
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| Secondary | Proportion of Participants With AEs at Day 169 | Proportion of participants with AEs at Day 169 | All Treated Participants | Posted | Number | Percentage of participants | Day 169 |
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| Secondary | Proportion of Participants With SAEs at Day 169 | Proportion of participants with SAEs at Day 169 | All Treated Participants | Posted | Number | Percentage of participants | Day 169 |
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| Secondary | Proportion of Participants With AEs Leading to Discontinuation at Day 169 | Proportion of participants with AEs leading to discontinuation at Day 169 | All Treated Participants | Posted | Number | Percentage of participants | Day 169 |
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| Secondary | Proportion of Participant Deaths at Day 169 | Proportion of participant deaths at Day 169 | All Treated Participants | Posted | Number | Percentage of participants | Day 169 |
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| Secondary | Proportion of Participants With Marked Laboratory Abnormalities at Day 169 | Proportion of participants with marked laboratory abnormalities at Day 169 | All Treated Participants | Posted | Number | Percentage of participants | Day 169 |
|
|
Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABATACEPT DURING DOUBLE-BLIND PERIOD | 0 | 213 | 6 | 213 | 39 | 213 | |
| EG001 | PLACEBO DURING DOUBLE-BLIND PERIOD | 0 | 211 | 9 | 211 | 43 | 211 | |
| EG002 | ABATACEPT DURING OPEN-LABEL PERIOD | 0 | 382 | 29 | 382 | 92 | 382 | |
| EG003 | ABATACEPT DURING OPEN-LABEL EXTENSION PERIOD | 0 | 322 | 20 | 322 | 103 | 322 | |
| EG004 | ABATACEPT DURING LONG-TERM EXTENSION PERIOD | 0 | 106 | 17 | 106 | 56 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric mucosa erythema | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic fibrosis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Carcinoma in situ of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute chest syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Erythrodermic psoriasis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| Aug 9, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
Not provided
Not provided
| Lost to Follow-up |
|
| Subject request discontinue treatment |
|
| Withdrawal by Subject |
|
| Other Reasons |
|
| Subject request to discontinue treatment |
|
| Lost to Follow-up |
|
| subject withdrew consent |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
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