A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2011-001460-22-GB
• Date of registration: 17/10/2011
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd.
• Public title: A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.
• Scientific title: A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A
• Date of first enrolment: 19/01/2012
• Target sample size: 86
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001460-22
• 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: yes; Other trial design description: 48-week blinded period followed by a 48-week open-label period; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, France, Germany, 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:
•Ability and willingness to give written informed consent and comply with the requirements of the study protocol
•Diagnosis of SSc, as defined using ACR criteria
•Disease duration of = 60 months (defined as time from the first non-Raynaud phenomenon manifestation)
•Age = 18 years
•= 15 and = 40 mRSS units at the screening visit
•Uninvolved skin at injection sites
•Active disease

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 66
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
•Rheumatic autoimmune disease other than SSc, including but not limited to, RA, systemic lupus erythematosis, mixed connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjögren syndrome and eosinophilic myalgia syndrome
•Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
•History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
•Evidence of moderately severe concomitant nervous system, renal, endocrine or GI disease, as determined by the Principal Investigator
•Pulmonary disease with FVC = 50% of predicted or a DLCO (hemoglobin corrected) = 40% of predicted


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

Health Condition(s) or Problem(s) studied

Systemic Sclerosis (SSc)
MedDRA version: 17.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

Trade Name: RoActemra
Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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

Primary end point(s): modified Rodnan Skin Score

Main Objective: •To assess the efficacy of treatment with TCZ 162 mg SC versus placebo SC given every week to patients with SSc, at Week 24 using the mRSS
•To assess the safety of treatment with TCZ 162 mg SC versus placebo SC given every week

Secondary Objective: •To assess the efficacy of TCZ 162 mg SC versus placebo on improvement of physical function (as measured by the Scleroderma Health Assessment Questionnaire–Disability Index [SHAQ-DI])
•To assess the efficacy of TCZ 162 mg SC versus placebo on patient’s global assessment
•To assess the efficacy of TCZ 162 mg SC versus placebo on improvement of the clinician's global assessment
•To assess the efficacy of TCZ 162 mg SC versus placebo on fatigue (as measured by Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue] score)
•To assess the efficacy of TCZ 162 mg SC versus placebo as measured on Pruritus 5-D Itch Scale (5-D Itch Scale)
•To assess the efficacy of TCZ 162 mg SC versus placebo at Week 48 on skin thickness using the mRSS
•To assess the proportion of patients with maintenance of mRSS response from Week 24 to Week 48.
•To characterize the PK and PD profile of TCZ 162 mg SC
•To assess the immunogenicity of TCZ 162 mg SC

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: week 24 and/or week 48

Secondary end point(s): •Change in HAQ-DI score from baseline at week 24 and week 48
•Change in patient’s global assessment from baseline at week 24 and week 48
•Change in clinician’s global assessment from baseline at week 24 and week 48
•Change in FACIT-F score from baseline at week 24 and week 48
•Change in Pruritus 5-D Itch scale from baseline at week 24 and week 48
•Change in mRSS from baseline at week 48
•Proportion of patients with mRSS at week 48 = mRSS at week 24
•Change in VAS scores from baseline (intestinal, breathing, Raynaud's, finger ulcers, overall disease VAS scores from SHAQ-DI) at weeks 24 and 48

Secondary ID(s)

WA27788

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 06/03/2016
• Date Completed: 16/06/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001460-22/results