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

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 Drug: adalimumab plus placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
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:

Genetics Home Reference related topics: rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis Steroids

Drug Information available for: Prednisone Adalimumab

U.S. FDA Resources

Further study details as provided by Carlomaurizio Montecucco, 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 ]

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 ]


Enrollment:	251
Study Start Date:	May 2007
Study Completion Date:	March 1, 2017
Primary Completion Date:	March 1, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: group A 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 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)
Placebo Comparator: group B 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 adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months Other Name: humira (adalimumab)

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Italy
IRCCS S. Matteo Hospital
Pavia, Italy, 27100

Sponsors and Collaborators

IRCCS Policlinico S. Matteo

Investigators


Principal Investigator:	carlomaurizio montecucco, MD	IRCCS S. Matteo Foundation, Pavia

More Information


Responsible Party:	Carlomaurizio Montecucco, Director, Academic Division of Rheumatology, IRCCS Policlinico S. Matteo and University of Pavia, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:	NCT00480272 History of Changes
Other Study ID Numbers:	CURE 2006-003843-22 ( EudraCT Number )
Study First Received:	May 29, 2007
Last Updated:	March 3, 2017
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by Carlomaurizio Montecucco, IRCCS Policlinico S. Matteo:


rheumatoid arthritis clinical remission

Additional relevant MeSH terms:


Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Adalimumab Prednisone Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 22, 2017

Prospective Study on Intensive Early Rheumatoid Arthritis Treatment (CURE)