Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

NCT00480272 | Completed Phase 4 DMC

• 2 other identifiers: CURE2006-003843-22
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; clinical remission

Outcome Measures

Primary Outcomes (1)

• to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28 </= 2.6

  52 weeks

Secondary Outcomes (1)

• 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

  24 months

Study Arms (2)

group A

EXPERIMENTAL

* 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

Drug: adalimumab, plus prednisone

group B

PLACEBO COMPARATOR

* 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

Drug: adalimumab plus placebo

Interventions

adalimumab, plus prednisone DRUG

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

Also known as: humira (adalimumab), deltacortene (prednisone)

group A

adalimumab plus placebo DRUG

adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months

Also known as: humira (adalimumab)

group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

IRCCS S. Matteo Hospital

Pavia, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab; deltacortene; Prednisone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• carlomaurizio montecucco, MD

  IRCCS S. Matteo Foundation, Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Academic Division of Rheumatology, IRCCS Policlinico S. Matteo and University of Pavia

Study Record Dates

• First Submitted: May 29, 2007
• First Posted: May 30, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 6, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)