A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.

• Register: EUCTR
• Last refreshed on: 23 September 2013
• Main ID: EUCTR2009-012759-12-AT
• Date of registration: 21/08/2009
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd.
• Public title: A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.
• Scientific title: 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. - FUNCTION
• Date of first enrolment: 14/09/2009
• Target sample size: 1128
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012759-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4

Countries of recruitment

Argentina, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Macedonia, the former Yugoslav Republic of, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

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- DMARDs should be withdrawn at least 2 weeks prior to baseline.

- 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 981
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 147

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis
MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methotrexate Disodium
CAS Number: 7413345
Other descriptive name: Methotrexate as methotrexate disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary endpoint is the proportion of patients with a DAS28 remission response (DAS28 < 2.6) at Week 24.

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.

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.

Timepoint(s) of evaluation of this end point: week 24

Secondary Outcome(s)

Secondary end point(s): change in total modified Sharp score (Time Frame: week 52)
clinical response: ACR20/ACR50/ACR70 (Time Frame: weeks 24 and 52)
physical function: HAQ-DI score (Time Frame: weeks 24 and 52)

Timepoint(s) of evaluation of this end point: weeks 24 and 52

Secondary ID(s)

NCT01007435

WA19926

2009-012759-12-GB

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd