Prospective Study on Intensive Early Rheumatoid Arthritis Treatment - Full Text View

Sponsor:	IRCCS Policlinico S. Matteo
Information provided by:	IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:	NCT00480272

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: adalimumab plus prednisone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Prednisone Adalimumab

U.S. FDA Resources

Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	240
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480272

Contacts

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

Locations

Italy
IRCCS S. Matteo Hospital	Recruiting
Pavia, Italy, 27100
Contact: roberto caporali, MD +390382501878 caporali@smatteo.pv.it
Sub-Investigator: Claudia Bonino, MD

Sponsors and Collaborators

IRCCS Policlinico S. Matteo

Investigators

Principal Investigator:

carlomaurizio montecucco, MD

IRCCS S. Matteo Foundation, Pavia

More Information

No publications provided

Responsible Party:	IRCCS S. Matteo Foundation, Pavia, Italy ( carlomaurizio Montecucco )
Study ID Numbers:	CURE, eudraCT n°: 2006-003843-22
Study First Received:	May 29, 2007
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00480272 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by IRCCS Policlinico S. Matteo:

rheumatoid arthritis
clinical remission

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid
Hormones, Hormone Substitutes, and Hormone Antagonists

Rheumatic Diseases
Adalimumab
Glucocorticoids
Hormones
Pharmacologic Actions
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 08, 2010