Prospective Study on Intensive Early Rheumatoid Arthritis Treatment - Tabular View

Tracking Information

First Received Date ^ICMJE

May 29, 2007

Last Updated Date

August 3, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00480272 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

Official Title ^ICMJE

A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

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)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: carlomaurizio montecucco, MD	+390382501878	montecucco@smatteo.pv.it
Contact: roberto caporali, MD	+390382501878	caporali@smatteo.pv.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00480272

Responsible Party

carlomaurizio Montecucco, IRCCS S. Matteo Foundation, Pavia, Italy

Study ID Numbers ^ICMJE

CURE, eudraCT n°: 2006-003843-22

Study Sponsor ^ICMJE

IRCCS Policlinico S. Matteo

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

carlomaurizio montecucco, MD

IRCCS S. Matteo Foundation, Pavia

Information Provided By

IRCCS Policlinico S. Matteo

Verification Date

August 2009

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