Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
IRCCS Policlinico S. Matteo |
---|---|
Information provided by: | IRCCS Policlinico S. Matteo |
ClinicalTrials.gov Identifier: | NCT00480272 |
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
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: adalimumab plus prednisone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 240 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Treatment group A 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + prednisone 50 mg/d tapered to 6.25 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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: carlomaurizio montecucco, MD | +390382501878 | montecucco@smatteo.pv.it |
Contact: roberto caporali, MD | +390382501878 | caporali@smatteo.pv.it |
Italy | |
IRCCS S. Matteo Hospital | Recruiting |
Pavia, Italy, 27100 | |
Contact: roberto caporali, MD +390382501878 caporali@smatteo.pv.it | |
Sub-Investigator: Claudia Bonino, MD |
Principal Investigator: | carlomaurizio montecucco, MD | IRCCS S. Matteo Foundation, Pavia |
Responsible Party: | IRCCS S. Matteo Foundation, Pavia, Italy ( carlomaurizio Montecucco ) |
Study ID Numbers: | CURE, eudraCT n°: 2006-003843-22 |
Study First Received: | May 29, 2007 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00480272 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
rheumatoid arthritis clinical remission |
Anti-Inflammatory Agents Prednisone Autoimmune Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Joint Diseases Arthritis, Rheumatoid Hormones, Hormone Substitutes, and Hormone Antagonists Rheumatic Diseases |
Adalimumab Glucocorticoids Hormones Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Anti-Inflammatory Agents Prednisone Autoimmune Diseases Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid Hormones, Hormone Substitutes, and Hormone Antagonists |
Rheumatic Diseases Adalimumab Glucocorticoids Hormones Pharmacologic Actions Musculoskeletal Diseases Therapeutic Uses Arthritis Connective Tissue Diseases Antirheumatic Agents |