Phase 3 N=511 Randomized Double-blind Treatment

Remission and Joint Damage Progression in Early Rheumatoid Arthritis

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00122382 ↗

Enrolled (actual)

511

Serious AEs

7.9%

Results posted

Jul 2010

Primary outcome: Primary: Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12 — 106; 59 participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Abatacept (Drug); placebo (Drug); methotrexate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12	106; 59	<0.001 sig
PRIMARY Mean Change From Baseline in Radiographic Total Score to Month 12	7.50; 6.67; 0.63; 1.06	<0.040 sig
PRIMARY Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period	345; 128; 29; 10; 11; 4	—
PRIMARY Number of Participants With Serious Adverse Events Reported During the Open-Label Period	29; 8; 4; 4; 3; 3	—
PRIMARY Number of Participants With SAEs With an Outcome of Death During the Open-label Period	1; 1	—
PRIMARY Incidence Rates of Autoimmune Disorders in ABA-Treated Participants	2.47; 1.30	—
PRIMARY Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants	78.37; 66.68	—
PRIMARY Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants	0.81; 0	—
PRIMARY Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period	1	—
PRIMARY Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period	2; 10; 24; 15; 0; 13	—
PRIMARY Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period	9; 5; 8; 1; 1; 14	—
SECONDARY Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12	147; 107	<0.001 sig
SECONDARY Number of Participants With Major Clinical Response (MCR) at Month 12	70; 30	<0.001 sig
SECONDARY Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12	-3.22; -2.49	<0.001 sig
SECONDARY Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12	184; 157	0.024 sig
SECONDARY Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12	11.68; 9.18; 8.15; 6.34	0.005 sig
SECONDARY Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12	5.48; 4.81; 0.50; 0.89; 2.03; 1.86	0.033 sig
SECONDARY 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)	3; 0; 1; 1	—
SECONDARY 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	13; 16	—
SECONDARY Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24	189; 178	—
SECONDARY Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24	5.91; 5.49; 0.59; 1.40; 1.83; 1.75	—
SECONDARY Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24	125; 92; 144; 114; 175; 150	—
SECONDARY 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	116; 87; 135; 107; 169; 150	—
SECONDARY Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)	0.66; 0.18	<0.001 sig
SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period	2; 4; 20; 20; 5; 6	—
SECONDARY Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period	3; 3; 1; 2; 1; 4	—

Summary

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

Eligibility Criteria

Inclusion Criteria

Diagnosis of rheumatoid arthritis (RA) = 4.5 mg/L (after amendment)
Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
Tender joints >=12 and swollen joints >=10

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00122382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.