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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 16 December 2017
Main ID:  NCT00480272
Date of registration: 29/05/2007
Prospective Registration: Yes
Primary sponsor: IRCCS Policlinico S. Matteo
Public title: Prospective Study on Intensive Early Rheumatoid Arthritis Treatment CURE
Scientific title: A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance
Date of first enrolment: May 2007
Target sample size: 251
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Name:     carlomaurizio montecucco, MD
Affiliation:  IRCCS S. Matteo Foundation, Pavia
Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: adalimumab plus placebo
Drug: adalimumab, plus prednisone
Primary Outcome(s)
to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28 [Time Frame: 52 weeks]
Secondary Outcome(s)
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]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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