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Prospective Study on Intensive Early Rheumatoid Arthritis Treatment (CURE)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
adalimumab, plus prednisone
adalimumab plus placebo
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, clinical remission

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS S. Matteo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

group A

group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
May 29, 2007
Last Updated
March 3, 2017
Sponsor
IRCCS Policlinico S. Matteo
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1. Study Identification

Unique Protocol Identification Number
NCT00480272
Brief Title
Prospective Study on Intensive Early Rheumatoid Arthritis Treatment
Acronym
CURE
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, clinical remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
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
Arm Title
group B
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
adalimumab, plus prednisone
Other Intervention Name(s)
humira (adalimumab), deltacortene (prednisone)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
adalimumab plus placebo
Other Intervention Name(s)
humira (adalimumab)
Intervention Description
adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
carlomaurizio montecucco, MD
Organizational Affiliation
IRCCS S. Matteo Foundation, Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS S. Matteo Hospital
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

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