Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420927
Status:
COMPLETED
Last Update Posted:
2012-04-18
First Post:
2007-01-09
Brief Title:
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multicenter Randomized Double-Period Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis OPTIMA
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMA
Brief Summary:
This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate MTX to that of MTX monotherapy ie placebo plus MTX in subjects with early rheumatoid arthritis RA
Detailed Description:
This was a 78-week multicenter randomized double-blind double-treatment period study designed to compare the safety and efficacy of adalimumab and MTX with placebo and MTX in subjects with early RA Subjects were randomized to receive adalimumab 40 mg every other week eow or placebo subcutaneous injections in combination with orally administered MTX for 26 weeks Period 1 All subjects in all arms received open-label MTX weekly throughout the study both Period 1 and Period 2
At Weeks 22 and 26 subjects were assessed for achievement of low disease activity defined as a DAS28 score below 32 DAS28 is a measure of RA disease activity calculated using the number of tender and swollen joints out of a total of 28 C-reactive protein level CRP a blood marker of inflammation and the patients global assessment of disease activity indicated by marking a 10 cm line between very good and very bad Subjects who achieved low disease activity at Week 22 and 26 in the adalimumab arm at the end of Period 1 were randomized to receive MTX monotherapy placebo and MTX or combination therapy adalimumab and MTX in a 11 ratio for the duration of Period 2 52 weeks ie to Week 78 of the study Subjects achieving low disease activity at Week 22 and 26 in the placebo arm MTX monotherapy at the end of Period 1 continued to receive MTX monotherapy and placebo injections in a blinded fashion for the duration of Period 2 Subjects failing to achieve low disease activity at Week 22 and 26 at the end of Period 1 received open-label combination therapy during Period 2 regardless of treatment assignment in Period 1
At Weeks 22 and 26 subjects were assessed for achievement of low disease activity defined as a DAS28 score below 32 DAS28 is a measure of RA disease activity calculated using the number of tender and swollen joints out of a total of 28 C-reactive protein level CRP a blood marker of inflammation and the patients global assessment of disease activity indicated by marking a 10 cm line between very good and very bad Subjects who achieved low disease activity at Week 22 and 26 in the adalimumab arm at the end of Period 1 were randomized to receive MTX monotherapy placebo and MTX or combination therapy adalimumab and MTX in a 11 ratio for the duration of Period 2 52 weeks ie to Week 78 of the study Subjects achieving low disease activity at Week 22 and 26 in the placebo arm MTX monotherapy at the end of Period 1 continued to receive MTX monotherapy and placebo injections in a blinded fashion for the duration of Period 2 Subjects failing to achieve low disease activity at Week 22 and 26 at the end of Period 1 received open-label combination therapy during Period 2 regardless of treatment assignment in Period 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-004139-31 | EUDRACT_NUMBER | None | None |