Prospective Study on Intensive Early Rheumatoid Arthritis Treatment (CURE)

IRCCS Policlinico S. Matteo

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: adalimumab plus placebo; Drug: adalimumab, plus prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT00480272

CURE

2006-003843-22 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 251 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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251 participants in 2 patient groups, including a placebo group

group A

Experimental group

Description:

* 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

Treatment:

Drug: adalimumab, plus prednisone

group B

Placebo Comparator group

Description:

* 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

Treatment:

Drug: adalimumab plus placebo