Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. 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.

Phase 1

• Conditions: Artritis ReumatoideRheumatoid Arthritis; MedDRA version: 12.0Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2009-012759-12-ES
• 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: 2009-09-23
• Study Completion: 2012-05-31
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1128

Inclusion Criteria

- adult patients at least 18 years of age with moderate to severe active RA of <2 years disease duration.

- no previous methotrexate or biologic agent.

- DMARDs should be withdrawn at least 2 weeks prior to baseline.

- weight ? 150kg.

- patients of reproductive potential must be using reliable methods of contraception.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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):<br>?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.<br>?Improvement in physical function over 12 months and maintenance of this effect at 24 months.<br>?Pharmacokinetics, immunogenicity and pharmacodynamics of TCZ in patients with early RA<br>?Safety and efficacy of TCZ administration in patients with early RA.;Primary end point(s): The primary endpoint is the proportion of patients with a DAS28 remission response (DAS28 < 2.6) at Week 24.