A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Reumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034137
• Other study ID #: ML22497
• Secondary ID: 2009-013316-12
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2009
• Last updated: November 2, 2015
• Start date: January 2010
• Est. completion date: September 2014

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >/=18 years of age

• early rheumatoid arthritis (disease symptoms <1 year) according to ACR criteria

• disease activity DAS28 >2.6

• body weight </=110kg, BMI </=36

Exclusion Criteria:

• rheumatic autoimmune disease other than RA

• current inflammatory joint disease other than RA

• previous treatment with any DMARD or biologic drug used in the treatment of RA

• intra-articular, parenteral or oral glucocorticoids used for the arthritis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• methotrexate
orally weekly in ascending dosages, starting at 10mg/week
• placebo MTX
orally weekly
• placebo TCZ
iv every 4 weeks
• tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained remission rate		DAS28 score assessed every 4 weeks up to week 104	No
Secondary	Progression of joint damage on X-ray assessment		weeks 52 and 104	No
Secondary	Clinical efficacy: ACR and EULAR response criteria		assessed every 4 weeks up to week 104	No
Secondary	Safety and tolerability: AEs, laboratory parameters		throughout study, laboratory parameters assessed every 4 weeks	No
Secondary	VAS pain + wellbeing, functional disability, quality of life		assessed every 4 weeks up to week 104	No