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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00122382




Registration number
NCT00122382
Ethics application status
Date submitted
19/07/2005
Date registered
22/07/2005
Date last updated
16/11/2010

Titles & IDs
Public title
Remission and Joint Damage Progression in Early Rheumatoid Arthritis
Scientific title
A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate
Secondary ID [1] 0 0
IM101-023
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 - placebo
Treatment: Drugs - methotrexate

Active comparator: ABA + MTX - abatacept 10 mg/kg intravenous (IV) + methotrexate

Active comparator: Placebo (PLA) + MTX - placebo IV + methotrexate


Treatment: Drugs: Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months

Treatment: Drugs: placebo
placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months

Treatment: Drugs: methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12
Timepoint [1] 0 0
Month 12
Primary outcome [2] 0 0
Mean Change From Baseline in Radiographic Total Score to Month 12
Timepoint [2] 0 0
Baseline, Month 12
Primary outcome [3] 0 0
Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period
Timepoint [3] 0 0
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Primary outcome [4] 0 0
Number of Participants With Serious Adverse Events Reported During the Open-Label Period
Timepoint [4] 0 0
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Primary outcome [5] 0 0
Number of Participants With SAEs With an Outcome of Death During the Open-label Period
Timepoint [5] 0 0
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Primary outcome [6] 0 0
Incidence Rates of Autoimmune Disorders in ABA-Treated Participants
Timepoint [6] 0 0
Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).
Primary outcome [7] 0 0
Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants
Timepoint [7] 0 0
Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
Primary outcome [8] 0 0
Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants
Timepoint [8] 0 0
Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
Primary outcome [9] 0 0
Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period
Timepoint [9] 0 0
Open-Label Period (Month 12 to Month 24)
Primary outcome [10] 0 0
Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period
Timepoint [10] 0 0
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Primary outcome [11] 0 0
Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period
Timepoint [11] 0 0
Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Secondary outcome [1] 0 0
Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12
Timepoint [1] 0 0
Month 12
Secondary outcome [2] 0 0
Number of Participants With Major Clinical Response (MCR) at Month 12
Timepoint [2] 0 0
Month 12
Secondary outcome [3] 0 0
Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12
Timepoint [3] 0 0
Baseline, Month 12
Secondary outcome [4] 0 0
Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12
Timepoint [4] 0 0
Month 12
Secondary outcome [5] 0 0
Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12
Timepoint [5] 0 0
Baseline, Month 12
Secondary outcome [6] 0 0
Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12
Timepoint [6] 0 0
Baseline, Month 12
Secondary outcome [7] 0 0
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)
Timepoint [7] 0 0
includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.
Secondary outcome [8] 0 0
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA
Timepoint [8] 0 0
Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Secondary outcome [9] 0 0
Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24
Timepoint [9] 0 0
Baseline, Month 24
Secondary outcome [10] 0 0
Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24
Timepoint [10] 0 0
Baseline, Month 24
Secondary outcome [11] 0 0
Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24
Timepoint [11] 0 0
Baseline, Month 24
Secondary outcome [12] 0 0
Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12
Timepoint [12] 0 0
Month 12, Month 24
Secondary outcome [13] 0 0
Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)
Timepoint [13] 0 0
Baseline, Month 12, Month 24
Secondary outcome [14] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period
Timepoint [14] 0 0
Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.
Secondary outcome [15] 0 0
Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period
Timepoint [15] 0 0
Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.

Eligibility
Key inclusion criteria
* Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3 weeks. No dose within 3 months prior to informed consent.
* C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)
* Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
* Tender joints >=12 and swollen joints >=10
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women and men who are not willing to use birth control
* Diagnosed with other rheumatic disease
* History of cancer within 5 years
* Active tuberculosis
* Treatment with another investigation drug within 28 days
* Active bacterial or viral infection

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
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
1052
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Malvern
Recruitment hospital [2] 0 0
Local Institution - Shenton Park
Recruitment postcode(s) [1] 0 0
3144 - Malvern
Recruitment postcode(s) [2] 0 0
6008 - Shenton 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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
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
Oklahoma
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
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Belgium
State/province [15] 0 0
Antwerpen
Country [16] 0 0
Belgium
State/province [16] 0 0
Bruxelles
Country [17] 0 0
Belgium
State/province [17] 0 0
Hasselt
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Brazil
State/province [19] 0 0
Goias
Country [20] 0 0
Brazil
State/province [20] 0 0
Parana
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio De Janeiro
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio Grande Do Sul
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Paulo
Country [24] 0 0
Canada
State/province [24] 0 0
Newfoundland and Labrador
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
Saskatchewan
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Prague 2
Country [29] 0 0
France
State/province [29] 0 0
Dijon
Country [30] 0 0
France
State/province [30] 0 0
Montpellier Cedex 5
Country [31] 0 0
France
State/province [31] 0 0
Nice Cedex 03
Country [32] 0 0
France
State/province [32] 0 0
Strasbourg Cedex
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Germany
State/province [35] 0 0
Leipzig
Country [36] 0 0
Italy
State/province [36] 0 0
Jesi(Ancona)
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Anyang
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Daegu
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Daejeon
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Mexico
State/province [42] 0 0
Distrito Federal
Country [43] 0 0
Mexico
State/province [43] 0 0
Estado De Mexico
Country [44] 0 0
Mexico
State/province [44] 0 0
Guanajuato
Country [45] 0 0
Mexico
State/province [45] 0 0
Jalisco
Country [46] 0 0
Mexico
State/province [46] 0 0
Michioacan
Country [47] 0 0
Mexico
State/province [47] 0 0
Morelos
Country [48] 0 0
Mexico
State/province [48] 0 0
Nuevo Leon
Country [49] 0 0
Mexico
State/province [49] 0 0
Chihuahua
Country [50] 0 0
Mexico
State/province [50] 0 0
San Luis Potosi
Country [51] 0 0
Netherlands
State/province [51] 0 0
Amsterdam
Country [52] 0 0
Netherlands
State/province [52] 0 0
Leiden
Country [53] 0 0
Netherlands
State/province [53] 0 0
Nijmegen
Country [54] 0 0
Poland
State/province [54] 0 0
Poznan
Country [55] 0 0
Poland
State/province [55] 0 0
Warszawa
Country [56] 0 0
Puerto Rico
State/province [56] 0 0
Ponce
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Moscow
Country [58] 0 0
South Africa
State/province [58] 0 0
Free State
Country [59] 0 0
South Africa
State/province [59] 0 0
Gauteng
Country [60] 0 0
South Africa
State/province [60] 0 0
Kwa Zulu Natal
Country [61] 0 0
South Africa
State/province [61] 0 0
Western Cape
Country [62] 0 0
Spain
State/province [62] 0 0
A Coruna
Country [63] 0 0
Spain
State/province [63] 0 0
Santander
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Greater Manchester
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Lanarkshire
Country [67] 0 0
United Kingdom
State/province [67] 0 0
North Yorkshire
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Northumberland

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/NCT00122382