Prospective Study on Intensive Early Rheumatoid Arthritis Treatment (CURE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by IRCCS Policlinico S. Matteo.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
IRCCS Policlinico S. Matteo
Information provided by:
IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00480272
First received: May 29, 2007
Last updated: August 3, 2009
Last verified: August 2009
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by IRCCS Policlinico S. Matteo:
Primary Outcome Measures:
- to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28 </= 2.6 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- subjects who maintain stable remission at 24 months; ACR 20,50,70 at month 4,8,12,24; DAS 28 at month 4,8,12,24; HAQ at week 0,4,8,12,24; radiographic progression at months 12, 24; safety of different treatment regimens [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| 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) |
Intervention Details:
Detailed Description:
-
Drug: adalimumab plus prednisone
- humira (adalimumab)
- deltacortene (prednisone)
adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo or prednisone 50 mg/po day then reduced to 6.25/po day
Other Names:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Active rheumatoid arthritis diagnosed for at least 6 weeks, but no more than 1 year, according to the revised 1987 ACR criteria
- Naïve to treatment with MTX
- Swollen joint count (SJC) > 8 tender joint count (TJC) > 8
- At screening CRP > 1.5 mg/dL (15 mg/L) or ESR ≥ 28 mm/h
- ≥ 1 joint erosion or RF positivity or anti-CCP positivity
- Age 18-70 years.
Exclusion Criteria:
- Rheumatic autoimmune disease other than RA
- Functional class IV
- Any surgical procedure within 12 weeks prior to baseline or planned during the study.
- Pregnancy or breast feeding.
- Evidence of significant concomitant disease
- Primary or secondary immunodeficiency
- active infection of any kind
- History of previously untreated infection with mycobacterium tuberculosis or current treatment for same.
- History of cancer
- Any history or presence of congestive heart failure (CHF) (New York Heart Association classification for CHF: Class III or IV).
- Any history of myocardial infarction within 5 years.
- History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of adalimumab or methotrexate.
- Positive serology for hepatitis B or C indicating active infection.
- Hemoglobin < 8.0 g/dL.
- Absolute neutrophil count (ANC) < 1.5 x 103/L.
- Liver function abnormality
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480272
Contacts
| Contact: carlomaurizio montecucco, MD | +390382501878 | montecucco@smatteo.pv.it |
| Contact: roberto caporali, MD | +390382501878 | caporali@smatteo.pv.it |
Locations
| Italy | |
| IRCCS S. Matteo Hospital | Recruiting |
| Pavia, Italy, 27100 | |
| Contact: roberto caporali, MD +390382501878 caporali@smatteo.pv.it | |
| Sub-Investigator: Claudia Bonino, MD | |
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
| Principal Investigator: | carlomaurizio montecucco, MD | IRCCS S. Matteo Foundation, Pavia |
More Information
No publications provided
| Responsible Party: | carlomaurizio Montecucco, IRCCS S. Matteo Foundation, Pavia, Italy |
| ClinicalTrials.gov Identifier: | NCT00480272 History of Changes |
| Other Study ID Numbers: | CURE, eudraCT n°: 2006-003843-22 |
| Study First Received: | May 29, 2007 |
| Last Updated: | August 3, 2009 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by IRCCS Policlinico S. Matteo:
|
rheumatoid arthritis clinical remission |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Prednisone Adalimumab |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 21, 2013