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

May 29, 2007
August 3, 2009
May 2007
December 2009   (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 ] [ Designated as safety issue: No ]
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 ]
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 ] [ Designated as safety issue: Yes ]
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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2010
December 2009   (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
Both
18 Years to 70 Years
No
Contact: carlomaurizio montecucco, MD +390382501878 montecucco@smatteo.pv.it
Contact: roberto caporali, MD +390382501878 caporali@smatteo.pv.it
Italy
 
NCT00480272
CURE, eudraCT n°: 2006-003843-22
Yes
carlomaurizio Montecucco, IRCCS S. Matteo Foundation, Pavia, Italy
IRCCS Policlinico S. Matteo
Not Provided
Principal Investigator: carlomaurizio montecucco, MD IRCCS S. Matteo Foundation, Pavia
IRCCS Policlinico S. Matteo
August 2009

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