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Prospective Study on Intensive Early Rheumatoid Arthritis Treatment (CURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlomaurizio Montecucco, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00480272
First received: May 29, 2007
Last updated: March 3, 2017
Last verified: March 2017

May 29, 2007
March 3, 2017
May 2007
March 1, 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00480272 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Prospective Study on Intensive Early Rheumatoid Arthritis Treatment
A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance
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

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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)
  • Drug: adalimumab plus placebo
    adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months
    Other Name: humira (adalimumab)
  • Experimental: group A
    • adalimumab 40 mg subcutaneous injections every other week from baseline to month 12
    • methotrexate orally weekly at initial dose of 10 mg rising to 20 mg weekly over 4 weeks in 2.5 mg increments, continued up to month 24.
    • prednisone orally 50 mg daily, gradually tapered up to 6.25 mg at week 7 and stopped at month 6
    Intervention: Drug: adalimumab, plus prednisone
  • Placebo Comparator: group B
    • adalimumab 40 mg subcutaneous injections every other week from baseline to the end of month 12
    • methotrexate orally oweekly at an initial dose of 10 mg rising to 20 mg weekly over 4 weeks in 2.5 mg increments, continued up to month 24.
    • placebo orally, stopped at month 6
    Intervention: Drug: adalimumab plus placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
March 1, 2017
March 1, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00480272
CURE
2006-003843-22 ( EudraCT Number )
Yes
Not Provided
No
Not Provided
Carlomaurizio Montecucco, IRCCS Policlinico S. Matteo
IRCCS Policlinico S. Matteo
Not Provided
Principal Investigator: carlomaurizio montecucco, MD IRCCS S. Matteo Foundation, Pavia
IRCCS Policlinico S. Matteo
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP