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.

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001460-22-GB

Enrollment

Registered

2011-10-17

Start date

2012-01-19

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

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

Interventions

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 Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Primary end point(s): modified Rodnan Skin Score;Timepoint(s) of evaluation of this end point: week 24; 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	—

Measure

Time frame

Primary end point(s): modified Rodnan Skin Score;Timepoint(s) of evaluation of this end point: week 24; 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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Canada, France, Germany, United Kingdom, 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