Prospective Study on Intensive Early Rheumatoid Arthritis Treatment
Information source: IRCCS Policlinico S. Matteo
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: adalimumab plus prednisone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: IRCCS Policlinico S. Matteo Official(s) and/or principal investigator(s):
carlomaurizio montecucco, MD, Principal Investigator, Affiliation: IRCCS S. Matteo Foundation, Pavia
Overall contact:
carlomaurizio montecucco, MD, Phone: +390382501878, Email: montecucco@smatteo.pv.it
Summary
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
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
carlomaurizio montecucco, MD, Phone: +390382501878, Email: montecucco@smatteo.pv.it
IRCCS S. Matteo Hospital, Pavia 27100, Italy; Recruiting
roberto caporali, MD, Phone: +390382501878, Email: caporali@smatteo.pv.it
Claudia Bonino, MD, Sub-Investigator
Additional Information
Starting date: May 2007
Ending date: December 2010
Last updated: May 15, 2008
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