A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012759-12-GB

Enrollment

1128

Registered

2009-08-17

Start date

2009-10-14

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Interventions

Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - adult patients at least 18 years of age with moderate to severe active RA of =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study. - treatment with methotrexate at anytime prior to baseline. - treatment with a biologic at anytime 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. - women who are pregnant or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary endpoint is the proportion of patients with a DAS28 remission response (DAS28 < 2.6) at Week 24.; Main Objective: To assess the efficacy of treatment with TCZ monotherapy and TCZ + MTX combination therapy, versus MTX monotherapy, with regard to the following primary endpoint in patients with early, moderate to severe rheumatoid arthritis (RA): • Proportion of patients who achieve DAS28 remission (DAS28 < 2.6) at 6 months. ; Secondary Objective: • Prevention of structural joint damage over 12 months and maintenance of this effect at 24 months. • Improvement in physical function over 12 months and maintenance of this effect at 24 months. • Pharmacokinetics, immunogenicity and pharmacodynamics of TCZ in patients with early RA • Safety and efficacy of TCZ administration in patients with early RA.	—

Measure

Time frame

Primary end point(s): The primary endpoint is the proportion of patients with a DAS28 remission response (DAS28 < 2.6) at Week 24.; Main Objective: To assess the efficacy of treatment with TCZ monotherapy and TCZ + MTX combination therapy, versus MTX monotherapy, with regard to the following primary endpoint in patients with early, moderate to severe rheumatoid arthritis (RA): • Proportion of patients who achieve DAS28 remission (DAS28 < 2.6) at 6 months. ; Secondary Objective: • Prevention of structural joint damage over 12 months and maintenance of this effect at 24 months. • Improvement in physical function over 12 months and maintenance of this effect at 24 months. • Pharmacokinetics, immunogenicity and pharmacodynamics of TCZ in patients with early RA • Safety and efficacy of TCZ administration in patients with early RA.

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Countries

Austria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026