Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480272
• Other study ID #: CURE
• Secondary ID: 2006-003843-22
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2007
• Last updated: March 3, 2017
• Start date: May 2007
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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
• adalimumab plus placebo
adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months

Locations

Country	Name	City	State
Italy	IRCCS S. Matteo Hospital	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28 </= 2.6		52 weeks
Secondary	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		24 months