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Prospective Study on Intensive Early Rheumatoid Arthritis Treatment (CURE)

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ClinicalTrials.gov Identifier: NCT00480272
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Carlomaurizio Montecucco, IRCCS Policlinico S. Matteo

Study Description
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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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: adalimumab, plus prednisone Drug: adalimumab plus placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : May 2007
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  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 [ Time Frame: 24 months ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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