Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480272
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2007-05-29
Brief Title:
Prospective Study on Intensive Early Rheumatoid Arthritis Treatment
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
A Phase IV Multicenter Randomized Double-blind Study prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab Induction of REmission and Maintenance
Status:
COMPLETED
Status Verified Date:
2017-03
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:
CURE
Brief Summary:
Hypothesis Early intensive treatment with anti-TNF agent plus methotrexate plus high dose prednisone may increase remission rate and may induce stable remission in Rheumatoid Arthritis Objective to evaluate induction of remission using adalimumab prednisone and methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone
Detailed Description:
Treatment group A 0 - 6 months Adalimumab 40 mg eow methotrexate rapidly titrated to 20 mg weekly prednisone 50 mgd tapered to 625 mg 6 - 12 months Adalimumab 40 mg eow plus methotrexate 20 mg weekly group B 0 - 6 months Adalimumab 40 mg eow methotrexate rapidly titrated to 20 mg weekly placebo 6 - 12 months Adalimumab 40 mg eow methotrexate rapidly titrated to 20 mg weekly
Follow up period - Open Label phase
Patients achieving clinical remission will be than treated only with MTX and observed for another 12 months period Patients who do not achieve clinical remission or patients who will experience a relapse of the disease will be treated according to standard of care SOC modalities
Follow up period - Open Label phase
Patients achieving clinical remission will be than treated only with MTX and observed for another 12 months period Patients who do not achieve clinical remission or patients who will experience a relapse of the disease will be treated according to standard of care SOC modalities
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 |
|---|---|---|---|
| 2006-003843-22 | EUDRACT_NUMBER | None | None |