A long-term 5-year study investigation whethetr tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies

• Register: EUCTR
• Last refreshed on: 14 April 2014
• Main ID: EUCTR2005-002909-23-SI
• Date of registration: 20/02/2006
• Prospective Registration: Yes
• Primary sponsor: F Hoffmann La-Roche AG
• Public title: A long-term 5-year study investigation whethetr tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies
• Scientific title: Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96
• Date of first enrolment: 16/03/2006
• Target sample size: 2420
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002909-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, China, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iceland, Israel, Italy, Lithuania, Mexico, Netherlands, Norway, Panama, Peru, Portugal, Russian Federation, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, 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:
•patients who have completed participation in one of the core studies
(e.g. WA17824, WA18062, WA18063, and WP18663) in adult rheumatoid
arthritis.
•inadequate response to a stable dose of MTX or other allowable Disease
Modifying Anti-Rheumatic Drug (DMARD).
•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 1711
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 357

Exclusion criteria:
•treatment with any investigational agent since the last administration
of study drug in core studies.
•treatment with iv gamma globulin, plasmapheresis or prosorba column
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since the last administration of study drug in core studies.
•treatment with an anti-tumor necrosis factor agent or anti-IL-1 agent,
or a T-cell costimulation modulator or any biologic since the last
administration of study drug in the core studies.


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

Health Condition(s) or Problem(s) studied

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

Rheumatoid arthritis
MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Trade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
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-

Primary Outcome(s)

Secondary Objective: •To explore the possibility of reducing concomitant steroid treatment
•To determine the long-term efficacy of 8 mg/kg tocilizumab (MRA) with regard to reduction in signs and symptoms

Primary end point(s): The primary parameters of interest are safety and long-term efficacy.
The following endpoints will be summarized descriptively:
Safety:
• The safety of tocilizumab (MRA) with regard to adverse events and
laboratory result abnormalities.
• Concomitant steroid treatment will be summarized by visit.
• Number of patients who withdraw from treatment.
Efficacy:
• The proportion of patients achieving an ACR20, ACR50 and ACR70
response by visit.
• The proportion of patients who maintain an ACR20, ACR50 or ACR70
response consecutively for 24, 48, 96 and 264 weeks.
• The individual components of the ACR core set will be summarized by
visit.
• Change in Disease Activity Score (DAS28) from baseline to weeks 24,
48, 96 and 264.
• The proportion of patients who are categorical DAS28 responders
(EULAR response) by visit.
• The proportion of patients who remain categorical DAS28 responders
(EULAR response) consecutively for 24, 48, 96 and 264 weeks.
• The proportion of patients who change from monotherapy to
combination treatment by visit.

Timepoint(s) of evaluation of this end point: Safety:
Throughout study
Efficacy:
1. At Week 24 (6 months)
2. At Week 48 (12 months)
3. At Week 96 (24 months)
4. At Week 264 (66 months)

Main Objective: To assess the long-term safety of 8 mg/kg tocilizumab (MRA) as monotherapy or in combination with background DMARD therapy(ies) with regard to adverse events and laboratory result abnormalities.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: N/A

Secondary end point(s): N/A

Secondary ID(s)

WA18696

2005-002909-23-ES

NCT00720798

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd