A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-018375-22-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-29
• Study Completion: 2013-08-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1262

Inclusion Criteria

Adult patients >= 18 years
Rheumatoid arthritis of >= 6 months duration
Swollen joint count (SJC) = 4 (66 joint count), and tender joint count (TJC) = 4 (68 joint count) both at screening and baseline visits
At screening, CRP = 10 mg/L (=1 mg/dL) and/or ESR =28 mm/h
Have to be on at least one permitted DMARD, which has been at a stable dose for at least 8 weeks prior to baseline

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1043
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 219

Exclusion Criteria

Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomisation
Prior history of or current inflammatory joint disease other than RA
Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20.
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified