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

Arm | Intervention/treatment |
---|---|
Experimental: group A
|
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:
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Placebo Comparator: group B
|
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)
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Italy | |
IRCCS S. Matteo Hospital | |
Pavia, Italy, 27100 |
Principal Investigator: | carlomaurizio montecucco, MD | IRCCS S. Matteo Foundation, Pavia |
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 |