A study investigating whether tocilizumab (study drug) prevents joint damage, and how safe it is, in patients with moderate to severe rheumatoid arthritis randomly divided to groups receiving treatment with tocilizumab and methotrexate or methotrexate and placebo.

A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. - LITHE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003733-14-FI

Enrollment

1170

Registered

2004-11-17

Start date

2005-03-23

Completion date

Unknown

Last updated

2022-01-24

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

Conditions

Rheumatoid Arthritis

Interventions

Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Current Sp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - adult patients at least 18 years of age with moderate to severe active RA for at least 6 months - inadequate response to a stable dose of MTX -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 1009 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 187

Exclusion criteria

Exclusion criteria: - major surgery (including joint surgery) within eight weeks before entering study, or planned surgery within 6 months after entering study -prior treatment failure with an anti-tumor necrosis factor agent - women who are prgenant or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objectives: To assess the efficacy of treatment with MRA versus placebo, in combination with methotrexate (MTX), with regard to the following three primary endpoints in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX: Reduction in signs and symptoms over 6 months, Prevention of structural joint damage over 12 months (with confirmation at 24 months), and Improvement in physical function over 12 months (with confirmation at 24 months). To assess the safety of MRA versus placebo, in combination with methotrexate (MTX), with regard to adverse events and laboratory assessments. ;Secondary Objective: Secondary Objectives: - To explore the pharmacokinetics, immunogenicity and pharmacodynamic parameters of MRA in this patient population - To assess long-term safety and efficacy of MRA administration in the defined patient population;Primary end point(s): Primary. 1. At Week 24 (6 months): Proportion of patients with ACR20 response 2. At Week 52 (12 months): (a) Change from baseline* in modified Sharp total radiographic score (b) Change in physical function as measured by the area under the curve for the change from baseline in the Health Assessment Questionnaire (HAQ) Disability Index 3. At Week 104 (24 months): (a) Change from baseline* in modified Sharp total radiographic score (confirmation of week 52 result) (b) Change in physical function as measured by the area under the curve for the change from baseline in the Health Assessment Questionnaire (HAQ) Disability Index *assessment taken prior to receiving first dose of study medication is considered baseline;Timepoint(s) of evaluation of this end point: 1. At week 24 (6 months) 2. At week 54 (12 months) 3. At week 104 (24 months)	—

Measure

Time frame

Main Objective: Primary Objectives: To assess the efficacy of treatment with MRA versus placebo, in combination with methotrexate (MTX), with regard to the following three primary endpoints in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX: Reduction in signs and symptoms over 6 months, Prevention of structural joint damage over 12 months (with confirmation at 24 months), and Improvement in physical function over 12 months (with confirmation at 24 months). To assess the safety of MRA versus placebo, in combination with methotrexate (MTX), with regard to adverse events and laboratory assessments. ;Secondary Objective: Secondary Objectives: - To explore the pharmacokinetics, immunogenicity and pharmacodynamic parameters of MRA in this patient population - To assess long-term safety and efficacy of MRA administration in the defined patient population;Primary end point(s): Primary. 1. At Week 24 (6 months): Proportion of patients with ACR20 response 2. At Week 52 (12 months): (a) Change from baseline* in modified Sharp total radiographic score (b) Change in physical function as measured by the area under the curve for the change from baseline in the Health Assessment Questionnaire (HAQ) Disability Index 3. At Week 104 (24 months): (a) Change from baseline* in modified Sharp total radiographic score (confirmation of week 52 result) (b) Change in physical function as measured by the area under the curve for the change from baseline in the Health Assessment Questionnaire (HAQ) Disability Index *assessment taken prior to receiving first dose of study medication is considered baseline;Timepoint(s) of evaluation of this end point: 1. At week 24 (6 months) 2. At week 54 (12 months) 3. At week 104 (24 months)

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Secondary

Measure	Time frame
Secondary end point(s): - percentage of patients with ACR20/50/70 responses (Time frame: Week 24, 52 & 104) - percentage of patients with ACR70 maintained for 6 months (Time frame: Week 24, 52 & 104) - mean changes in parameters of ACR core set (Time frame: Week 24, 52 & 104) - AEs, laboratory parameters, vital signs. Time frame:Throughout study) ;Timepoint(s) of evaluation of this end point: 1. At week 24 (6 months) 2. At week 54 (12 months) 3. At week 104 (24 months)	—

Measure

Time frame

Secondary end point(s): - percentage of patients with ACR20/50/70 responses (Time frame: Week 24, 52 & 104) - percentage of patients with ACR70 maintained for 6 months (Time frame: Week 24, 52 & 104) - mean changes in parameters of ACR core set (Time frame: Week 24, 52 & 104) - AEs, laboratory parameters, vital signs. Time frame:Throughout study) ;Timepoint(s) of evaluation of this end point: 1. At week 24 (6 months) 2. At week 54 (12 months) 3. At week 104 (24 months)

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Countries

Australia, Brazil, China, Denmark, Finland, France, Greece, Italy, Mexico, Norway, Poland, South Africa, Spain, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

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