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
Sponsor:
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
  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:
    Drug: adalimumab plus 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:
    • humira (adalimumab)
    • deltacortene (prednisone)
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014