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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01142726




Registration number
NCT01142726
Ethics application status
Date submitted
3/06/2010
Date registered
11/06/2010
Date last updated
14/01/2016

Titles & IDs
Public title
Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
Scientific title
A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA
Secondary ID [1] 0 0
2010-018674-20
Secondary ID [2] 0 0
IM101-226
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - Methotrexate
Treatment: Drugs - Abatacept placebo
Treatment: Drugs - Methotrexate placebo

Active comparator: Abatacept, 125 mg, plus methotrexate, 2.5 mg - Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period

Active comparator: Methotrexate, 2.5 mg, plus abatacept placebo - Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period

Active comparator: Abatacept, 125 mg, plus methotrexate placebo - Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period


Treatment: Drugs: Abatacept
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months

Treatment: Drugs: Methotrexate
Tablets, oral, 2.5 mg, once weekly, 12 months

Treatment: Drugs: Abatacept placebo
Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months

Treatment: Drugs: Methotrexate placebo
Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18
Timepoint [1] 0 0
Randomization to Months 12 and 18
Secondary outcome [1] 0 0
Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18
Timepoint [1] 0 0
Randomization to Months 12 and 18
Secondary outcome [2] 0 0
Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time - Intent to Treat Population
Timepoint [2] 0 0
Randomization to Month 24
Secondary outcome [3] 0 0
Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18
Timepoint [3] 0 0
Baseline to Month 18
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18
Timepoint [4] 0 0
Randomization to Month 18
Secondary outcome [5] 0 0
Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time
Timepoint [5] 0 0
Randomization to Month 18
Secondary outcome [6] 0 0
Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time
Timepoint [6] 0 0
Randomization to Month 24
Secondary outcome [7] 0 0
Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Over Time
Timepoint [7] 0 0
Randomization to Month 18
Secondary outcome [8] 0 0
Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores of Short Form-36 (SF-36)
Timepoint [8] 0 0
Randomization to Months 6, 12, and 18
Secondary outcome [9] 0 0
Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)
Timepoint [9] 0 0
Randomization to Month 18
Secondary outcome [10] 0 0
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period
Timepoint [10] 0 0
Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period
Secondary outcome [11] 0 0
Adverse Events (AEs) of Interest During the Treatment Period
Timepoint [11] 0 0
Day 1 to 56 days following last dosing day (Day 365)
Secondary outcome [12] 0 0
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality During Treatment Period
Timepoint [12] 0 0
Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)
Secondary outcome [13] 0 0
Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time During Withdrawal Period- Treated Participants in Remission at Month 12
Timepoint [13] 0 0
End of Treatment Period (Month 12) to End of Withdrawal Period (Month 24)
Secondary outcome [14] 0 0
Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) Over Time in Treatment Period and Withdrawal Period
Timepoint [14] 0 0
Randomization to Month 24
Secondary outcome [15] 0 0
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) and Discontinuations Due to AEs During the Full Study (All Periods)
Timepoint [15] 0 0
Day 1 to 56 days post last dose in the study, up to Month 30
Secondary outcome [16] 0 0
Adverse Events (AEs) of Interest During the Withdrawal Period
Timepoint [16] 0 0
Last dose in TP + 57 days, up to Month 24
Secondary outcome [17] 0 0
Adverse Events (AEs) of Interest During the Re-exposure Period
Timepoint [17] 0 0
First dose in Re-exposure period up to last dose of Re-exposure Period + 56 days
Secondary outcome [18] 0 0
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Withdrawal Period
Timepoint [18] 0 0
Last dose in TP + 57 days, up to Month 24
Secondary outcome [19] 0 0
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Re-exposure Period
Timepoint [19] 0 0
Start of re-exposure period to 56 days post last dose, up to Month 30

Eligibility
Key inclusion criteria
Key

* Presence of active clinical synovitis in at least 2 joints, 1 of which must have been a small joint, for a minimum of 8 weeks prior to screening
* Onset of persistent symptoms = 2 years prior to screening
* Positive test result for anticyclic citrullinated peptides 2
* Methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for =4 weeks and no methotrexate dose for 1 month prior to screening visit
* Biologic naive, including no treatment with an investigational biologic prior to screening
* Disease Activity Score 28 based on C-reactive protein score =3.2 at screening
* Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization
* If receiving oral corticosteroids, on a stable low dose (= 10 mg/day prednisone equivalent) for at least 4 weeks
* Able to undergo magnetic resonance imaging

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus)
* Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization
* Scheduled for or anticipating joint replacement surgery
* Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
* History of malignancy in the last 5 years
* Any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection
* At risk for tuberculosis
* Evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
511
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Cairns
Recruitment hospital [2] 0 0
Local Institution - Maroochydore
Recruitment hospital [3] 0 0
Local Institution - Woodville
Recruitment hospital [4] 0 0
Local Institution - Heidelberg
Recruitment hospital [5] 0 0
Local Institution - Malvern
Recruitment hospital [6] 0 0
Local Institution - Victoria Park
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Belgium
State/province [15] 0 0
Kortrijk
Country [16] 0 0
Belgium
State/province [16] 0 0
Merksem
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Denmark
State/province [19] 0 0
Hjorring
Country [20] 0 0
Finland
State/province [20] 0 0
Helsinki
Country [21] 0 0
Finland
State/province [21] 0 0
Tampere
Country [22] 0 0
France
State/province [22] 0 0
Chambray Les Tours
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Paris Cedex 14
Country [25] 0 0
France
State/province [25] 0 0
Poitiers
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Hildesheim
Country [28] 0 0
Germany
State/province [28] 0 0
Muenchen
Country [29] 0 0
Italy
State/province [29] 0 0
Ancona
Country [30] 0 0
Italy
State/province [30] 0 0
Siena
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Daegu
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Daejeon
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Mexico
State/province [34] 0 0
Estado De Mexico
Country [35] 0 0
Mexico
State/province [35] 0 0
Jalisco
Country [36] 0 0
Mexico
State/province [36] 0 0
Nuevo Leon
Country [37] 0 0
Mexico
State/province [37] 0 0
Yucatan
Country [38] 0 0
Mexico
State/province [38] 0 0
Chihuahua
Country [39] 0 0
Mexico
State/province [39] 0 0
Queretaro
Country [40] 0 0
Mexico
State/province [40] 0 0
San Luis Potosi
Country [41] 0 0
Poland
State/province [41] 0 0
Lublin
Country [42] 0 0
Poland
State/province [42] 0 0
Poznan
Country [43] 0 0
Poland
State/province [43] 0 0
Torun
Country [44] 0 0
Poland
State/province [44] 0 0
Warszawa
Country [45] 0 0
Poland
State/province [45] 0 0
Wroc#aw
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Moscow
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Tver
Country [48] 0 0
South Africa
State/province [48] 0 0
Gauteng
Country [49] 0 0
South Africa
State/province [49] 0 0
Kwa Zulu Natal
Country [50] 0 0
South Africa
State/province [50] 0 0
Western Cape
Country [51] 0 0
Sweden
State/province [51] 0 0
Goteborg
Country [52] 0 0
Sweden
State/province [52] 0 0
Linkoping
Country [53] 0 0
Sweden
State/province [53] 0 0
Malmo
Country [54] 0 0
Sweden
State/province [54] 0 0
Stockholm
Country [55] 0 0
Sweden
State/province [55] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01142726