Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Active Comparator |
| |
| Adalimumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population | Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N). The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage. To qualify a ACR20 score, patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation). Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale. | Day 1 to Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population | n=number of participants with a pre-specified local injection site reaction event, N=number of participants at risk. Proportion (%) = n/N. 12 Months includes data up to 56 days post last dose of the first 12 months Period or start of the first dose of second 12 months period. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Associates, Pc | Birmingham | Alabama | 35205 | United States | ||
| University Of Alabama At Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34878629 | Derived | Jabado O, Maldonado MA, Schiff M, Weinblatt ME, Fleischmann R, Robinson WH, He A, Patel V, Greenfield A, Saini J, Galbraith D, Connolly SE. Differential Changes in ACPA Fine Specificity and Gene Expression in a Randomized Trial of Abatacept and Adalimumab in Rheumatoid Arthritis. Rheumatol Ther. 2022 Apr;9(2):391-409. doi: 10.1007/s40744-021-00404-x. Epub 2021 Dec 8. | |
| 31819995 |
Not provided
Not provided
869 enrolled; 648 randomized; 646 randomized and treated. Reasons for not randomized: 4 pregnancy; 23 lost to follow-up; 133 administrative reasons by Sponsor; 4 no longer met study criteria; 7 other; 50 had reasons missing. Two participants randomized/not treated: no longer met study criteria. Randomization stratified by DAS28-CRP>5.1, <=5.1
28-October-2009 to 23-November-2012. Study conducted in biologic-naive participants with Rheumatoid Arthritis (RA) who have failed on methotrexate therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 125 mg Abatacept SC Weekly | Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adalimumab | Drug | Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days) |
|
|
| Day 1 to 12 Months |
| Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population | Incidence Rate: (incidence/100 person-years) = number of participants with event * 100 /exposure (person-years) Exposure (person-years) = the sum over all participants of the exposure per participant in the 24 months (censored at the time of first occurrence of AE) expressed in days, divided by 365.25. The 24 Month Period includes data up to 56 days post the last dose in the 24 month period. Poisson distribution used to construct the 95% CIs. | Day 1 to Day 729 |
| Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population | Plain radiographs of hands and feet taken at baseline (BL), Day 365, and Day 729. BL and Day 365 radiographs were re-read concurrent with Day 729 films by readers blinded to sequence and treatment (a second pre-specified reading campaign). SDC defined as amount of change for which anything smaller could not be reliably distinguished from random error in measurement of simultaneously read films. Non-progression defined: change from BL (Day 1, prior to dosing) in total score less than, equal to (<=) SDC(2.2). Proportion n/m (%)=number meeting criteria (n); number analyzed (m). SDC calculated as SD/sqrt(2)*1.96/sqrt(2)with standard deviation (SD) of paired differences of change from BL in total score between 2 readers; squared root(sqrt). mSvdHS=summary of erosion severity in 32 hand and 12 foot joints. Hand joints scored 0 to 5; foot joints 0 to 10 with 0=no erosion and higher numbers indicating greater erosion severity. BL: radiographic data within 14 days or less of first dose. | Baseline to Day 729 |
| Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population | Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post-last dose of first 12 months or start of first dose of second 12 months); denominator was overall total exposure (person-years) within this period, calculated as sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | Day 1 to Day 365 |
| Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population | Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, and all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post the last dose of the 24 Months period); denominator was overall total exposure (person-years) within this period, which was calculated as the sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express the rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | Day 1 to Day 729 |
| Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population | The induction of autoantibodies was defined as participant's antinuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) converting from a negative status at baseline to a positive status at a post-baseline measurement time point (Day 365 or Day 729). Proportion (%) = n/m, where n=number of participants with positive ANA or dsDNA at a time point and m=number of participants who had negative ANA or dsDNA at baseline. Blood samples were first tested for ANA by indirect fluorescent assay using HEp-2 Cell Line Substrate, and when positive, samples were further tested for anti-dsDNA by indirect fluorescent assay using Crithidia Luciliae Substrate. | Day 1 to Day 729 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Clinical And Translational Research Center Of Alabama, Pc | Tuscaloosa | Alabama | 35406 | United States |
| Sun Valley Arthritis Center, Ltd. | Peoria | Arizona | 85381 | United States |
| Mercy Clinic Hot Springs Communities | Hot Springs | Arkansas | 71913 | United States |
| Talbert Medical Group | Huntington Beach | California | 92646 | United States |
| Allergy & Rheumatology Medical Clinic, Inc. | La Jolla | California | 92037 | United States |
| Valerius Med Group & Res Ctr Of Greater Long Beach, Inc. | Long Beach | California | 90806 | United States |
| Irene Y. Tong | Pasadena | California | 91107 | United States |
| San Diego Arthritis Medical Clinic | San Diego | California | 92108 | United States |
| Healthcare Partners Medical Group | Torrance | California | 90503 | United States |
| Drs. Goldin, Nies, Klashman & Eng | Torrance | California | 90505 | United States |
| Inland Rheumatology & Osteoporosis Medical Group | Upland | California | 91786 | United States |
| Arthritis And Rheumatic Disease Specialties | Aventura | Florida | 33180 | United States |
| University Of Florida College Of Medicine At Jacksonville | Gainesville | Florida | 32610 | United States |
| Center For Arthritis And Rheumatic Diseases | Miami | Florida | 33173 | United States |
| Arthritis Research Of Florida, Inc. | Palm Harbor | Florida | 34684 | United States |
| Sarasota Arthritis Research Center | Sarasota | Florida | 34239 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| West Broward Rheumatology Associates | Tamarac | Florida | 33321 | United States |
| Lovelace Scientific Resources, Inc | Venice | Florida | 34292 | United States |
| Arthritis & Rheumatology Of Georgia | Atlanta | Georgia | 30342 | United States |
| Laureate Clinical Research Group | Atlanta | Georgia | 30342 | United States |
| Arthritis Center Of North Georgia | Gainesville | Georgia | 30501 | United States |
| St. Luke'S Clinic - Rheumatology | Boise | Idaho | 83702 | United States |
| Coeur D'Alene Arthrit Clin | Coeur d'Alene | Idaho | 83814 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Rockford Orthopedic Associates, Ltd. | Rockford | Illinois | 61107 | United States |
| Physicians Clinic Of Iowa | Cedar Rapids | Iowa | 52401 | United States |
| Center For Arthritis And Osteoporosis | Elizabethtown | Kentucky | 42701 | United States |
| Bluegrass Community Research, Inc. | Lexington | Kentucky | 40504 | United States |
| Klein And Associates, M.D., Pa | Cumberland | Maryland | 21502 | United States |
| The Center For Rheumatology And Bone Research | Wheaton | Maryland | 20902 | United States |
| Brigham And Women'S Hospital | Boston | Massachusetts | 02115 | United States |
| Mansfield Health Center | Mansfield | Massachusetts | 02048 | United States |
| Associated Internal Medicine Specialists | Battle Creek | Michigan | 49015 | United States |
| Rheumatology Pc | Kalamazoo | Michigan | 49009 | United States |
| Arthritis Associates Of Mississippi | Jackson | Mississippi | 39202 | United States |
| Physician Groups, Lc Dba | St Louis | Missouri | 63131 | United States |
| Arthritis Center Of Reno | Reno | Nevada | 89502 | United States |
| Seacoast Arthritis And Osteoporosis Center | Dover | New Hampshire | 03820 | United States |
| Nashua Rheumatology | Nashua | New Hampshire | 03060 | United States |
| Arthritis And Osteoporosis Associates Of New Mexico | Las Cruces | New Mexico | 88011 | United States |
| North Shore Lij Health System | Lake Success | New York | 11042 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Rheumatology Associates Of Long Island | Smithtown | New York | 11787 | United States |
| Asheville Rheumatology & Osteoporosis Research Asso P. A. | Asheville | North Carolina | 28803 | United States |
| Carolina Pharmaceutical Research | Statesville | North Carolina | 28625 | United States |
| Health Research Of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | United States |
| Lynn Health Sciences Institute | Oklahoma City | Oklahoma | 73112 | United States |
| East Penn Rheumatology Associates, P.C. | Bethlehem | Pennsylvania | 18015 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Research Center Of Reading, Llp | Wyomissing | Pennsylvania | 19610 | United States |
| Low Country Rheumatology, Pa | Charleston | South Carolina | 29406 | United States |
| Columbia Arthritis Center, P.A. | Columbia | South Carolina | 29204 | United States |
| Lovelace Scientific Resources, Inc. | Austin | Texas | 78758 | United States |
| Arthritis Centers Of Texas | Dallas | Texas | 75246 | United States |
| Rheumatic Disease Clinical Research Center, Llc | Houston | Texas | 77004 | United States |
| Center For Arthritis & Rheumatic Diseases, Pc | Chesapeake | Virginia | 23320 | United States |
| Rockwood Research Center | Spokane | Washington | 99202 | United States |
| Mountain State Clinical Research | Clarksburg | West Virginia | 26301 | United States |
| Rheumatic Disease Center | Glendale | Wisconsin | 53217 | United States |
| Local Institution | Ciudad Autonoma de Beunos Aire | Buenos Aires | 1431 | Argentina |
| Local Institution | Ciudad Autonoma de Buenos Aire | Buenos Aires | 1015 | Argentina |
| Local Institution | Ciudad Autonoma de Buenos Aire | Buenos Aires | C1428DQG | Argentina |
| Local Institution | Ciudad Autonoma | Buenos Aires | CP1425A WC | Argentina |
| Local Institution | Quilmes | Buenos Aires | 1878 | Argentina |
| Local Institution | Cordoba, Crd | Córdoba Province | X5016KEH | Argentina |
| Local Institution | Córdoba | Córdoba Province | 5000 | Argentina |
| Local Institution | San Juan | San Juan Province | 5400 | Argentina |
| Local Institution | Rosario | Santa Fe Province | 2000 | Argentina |
| Local Institution | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Local Institution | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Local Institution | Hamilton | Ontario | L8N 1Y2 | Canada |
| Local Institution | Québec | Quebec | G1V 3M7 | Canada |
| Local Institution | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Local Institution | Santiago | Providencia | Chile |
| Local Institution | Bellavista | Callao 2 | Peru |
| Local Institution | Lima | Lima Province | LIMA 11 | Peru |
| Local Institution | Lima | Lima Province | Peru |
| Local Institution | Lima | LIMA 27 | Peru |
| Local Institution | Lima | LIMA 33 | Peru |
| Keystone EC, Ahmad HA, Yazici Y, Bergman MJ. Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials. Rheumatology (Oxford). 2020 Aug 1;59(8):2090-2098. doi: 10.1093/rheumatology/kez455. |
| 31642045 | Derived | Fleischmann R, Weinblatt M, Ahmad H, Maldonado MA, Alemao E, Ye J, Schiff M. Efficacy of Abatacept and Adalimumab in Patients with Early Rheumatoid Arthritis With Multiple Poor Prognostic Factors: Post Hoc Analysis of a Randomized Controlled Clinical Trial (AMPLE). Rheumatol Ther. 2019 Dec;6(4):559-571. doi: 10.1007/s40744-019-00174-7. Epub 2019 Oct 22. |
| 27111089 | Derived | Fleischmann R, Connolly SE, Maldonado MA, Schiff M. Brief Report: Estimating Disease Activity Using Multi-Biomarker Disease Activity Scores in Rheumatoid Arthritis Patients Treated With Abatacept or Adalimumab. Arthritis Rheumatol. 2016 Sep;68(9):2083-9. doi: 10.1002/art.39714. |
| 27110385 | Derived | Schiff M, Weinblatt ME, Valente R, Citera G, Maldonado M, Massarotti E, Yazici Y, Fleischmann R. Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration. RMD Open. 2016 Apr 19;2(1):e000210. doi: 10.1136/rmdopen-2015-000210. eCollection 2016. |
| 26473625 | Derived | Fleischmann R, Weinblatt ME, Schiff M, Khanna D, Maldonado MA, Nadkarni A, Furst DE. Patient-Reported Outcomes From a Two-Year Head-to-Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Jul;68(7):907-13. doi: 10.1002/acr.22763. |
| 26359449 | Derived | Sokolove J, Schiff M, Fleischmann R, Weinblatt ME, Connolly SE, Johnsen A, Zhu J, Maldonado MA, Patel S, Robinson WH. Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial. Ann Rheum Dis. 2016 Apr;75(4):709-14. doi: 10.1136/annrheumdis-2015-207942. Epub 2015 Sep 10. |
| 23962455 | Derived | Schiff M, Weinblatt ME, Valente R, van der Heijde D, Citera G, Elegbe A, Maldonado M, Fleischmann R. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014 Jan;73(1):86-94. doi: 10.1136/annrheumdis-2013-203843. Epub 2013 Aug 20. |
| 23169319 | Derived | Weinblatt ME, Schiff M, Valente R, van der Heijde D, Citera G, Zhao C, Maldonado M, Fleischmann R. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013 Jan;65(1):28-38. doi: 10.1002/art.37711. |
| FG001 | 40 mg Adalimumab SC Biweekly | Adalimumab 40 mg, biweekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized and treated participants who started the 12 month period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept | Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. |
| BG001 | Adalimumab | Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population | Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N). The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage. To qualify a ACR20 score, patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation). Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale. | The intent to treat (ITT) analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 206/318 and 208/328 in the abatacept and adalimumab arms, respectively. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 365 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population | n=number of participants with a pre-specified local injection site reaction event, N=number of participants at risk. Proportion (%) = n/N. 12 Months includes data up to 56 days post last dose of the first 12 months Period or start of the first dose of second 12 months period. | The ITT analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 12/318, 30/328 in abatacept and adalimumab, respectively. CI based on normal approximation. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to 12 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population | Incidence Rate: (incidence/100 person-years) = number of participants with event * 100 /exposure (person-years) Exposure (person-years) = the sum over all participants of the exposure per participant in the 24 months (censored at the time of first occurrence of AE) expressed in days, divided by 365.25. The 24 Month Period includes data up to 56 days post the last dose in the 24 month period. Poisson distribution used to construct the 95% CIs. | ITT population: all participants randomized into the study who received at least one dose of study drug. Participants with a pre-specified local injection site event at 24 Months: 13, 34, in abatacept and adalimumab arms, respectively. 24 Month Exposure=579.21, 532.99, respectively. | Posted | Number | 95% Confidence Interval | incidence/100 person years | Day 1 to Day 729 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population | Plain radiographs of hands and feet taken at baseline (BL), Day 365, and Day 729. BL and Day 365 radiographs were re-read concurrent with Day 729 films by readers blinded to sequence and treatment (a second pre-specified reading campaign). SDC defined as amount of change for which anything smaller could not be reliably distinguished from random error in measurement of simultaneously read films. Non-progression defined: change from BL (Day 1, prior to dosing) in total score less than, equal to (<=) SDC(2.2). Proportion n/m (%)=number meeting criteria (n); number analyzed (m). SDC calculated as SD/sqrt(2)*1.96/sqrt(2)with standard deviation (SD) of paired differences of change from BL in total score between 2 readers; squared root(sqrt). mSvdHS=summary of erosion severity in 32 hand and 12 foot joints. Hand joints scored 0 to 5; foot joints 0 to 10 with 0=no erosion and higher numbers indicating greater erosion severity. BL: radiographic data within 14 days or less of first dose. | ITT population: all subjects randomized into the study who received at least one dose of study drug. Number analyzed: m=number of ITT participants with both BL and post-BL total score: Day 365: m=295, 297;Day 729 m=257 and 260, in abatacept and adalimumab arms, respectively. n=number without progression. CI based on normal approximation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Day 729 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population | Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post-last dose of first 12 months or start of first dose of second 12 months); denominator was overall total exposure (person-years) within this period, calculated as sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs. | Posted | Number | 95% Confidence Interval | incidence/100 person-years | Day 1 to Day 365 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population | Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, and all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post the last dose of the 24 Months period); denominator was overall total exposure (person-years) within this period, which was calculated as the sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express the rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs. | Posted | Number | 95% Confidence Interval | incidence/100 person-years | Day 1 to Day 729 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population | The induction of autoantibodies was defined as participant's antinuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) converting from a negative status at baseline to a positive status at a post-baseline measurement time point (Day 365 or Day 729). Proportion (%) = n/m, where n=number of participants with positive ANA or dsDNA at a time point and m=number of participants who had negative ANA or dsDNA at baseline. Blood samples were first tested for ANA by indirect fluorescent assay using HEp-2 Cell Line Substrate, and when positive, samples were further tested for anti-dsDNA by indirect fluorescent assay using Crithidia Luciliae Substrate. | ITT population was defined as all participants randomized into the study who received at least one dose of study drug; number analyzed was ITT participants with data at each time point and who had negative ANA or dsDNA at baseline (m) | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 729 |
|
Includes data up to 56 days post the last dose in the 24 months period.
Note: One participant in the abatacept arm had an SAE with no preferred term identified. Therefore, there were 44 participants with SAEs reported in the Outcome measure on the Rate of SAEs but since a preferred term was not identified, a total of 43 are identified in the SAEs below.
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 | Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. | 43 | 318 | 237 | 318 | ||
| EG001 | Adalimumab | Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. | 54 | 328 | 232 | 328 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Human papilloma virus test positive | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bursitis infective staphylococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Benign pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Histoplasmosis disseminated | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D007162 | Immunoproteins |
Not provided
Not provided
| Male |
|
| South America |
|
| Non-Inferiority or Equivalence |
Analysis tested for non-inferiority. Abatacept will be considered non-inferior to adalimumab if the upper limit of the 95% two-sided CI of difference in ACR20 response rates between the adalimumab arm and the abatacept arm is smaller than or equal to 12%. Estimate and 95% confidence interval (CI) for difference based on minimum risk weights method with randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP). |
|
|
|
Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
|
|
|
| OG001 | Adalimumab | Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. |
|
|
|
| OG001 | Adalimumab | Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. |
|
|
|
| OG001 | Adalimumab | Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. |
|
|
|
| OG001 |
| Adalimumab |
Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX. |
|
|
|