Phase 3
N=87
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
Sclerosis, Systemic
Bottom Line
View on ClinicalTrials.gov: NCT01532869 ↗Enrolled (actual)
87
Serious AEs
33.7%
Results posted
Nov 2015
Primary outcome: Primary: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 — -1.22; -3.92 unit on a scale — p=0.0915
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); tocilizumab [RoActemra/Actemra] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 |
-1.22; -3.92 | 0.0915 |
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
90.9; 97.7; 34.1; 32.6 | — |
| SECONDARY Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) |
5.81; 5.38; 8.54; 4.42; 2.41; 1.13 | 0.9336 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48 |
0.118; 0.137; 0.205; -0.002 | 0.8503 |
| SECONDARY Change From Baseline in Clinician's Global Assessment at Week 24 and Week 48 |
-7.25; -8.24; -9.39; -18.41 | 0.8118 |
| SECONDARY Change From Baseline in Patient's Global Assessment at Week 24 and Week 48 |
1.53; -2.33; -2.70; -11.00 | 0.4063 |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48 |
1.26; 2.68; 0.36; 3.11 | 0.5197 |
| SECONDARY Change From Baseline in 5-D Itch Scale at Week 24 and Week 48 |
-1.73; -0.94; -1.08; -2.19 | 0.3651 |
| SECONDARY Change From Baseline in mRSS at Week 48 |
-2.77; -6.33 | 0.0579 |
| SECONDARY Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48 |
44.4; 68.2 | 0.2159 |
| SECONDARY Change From Baseline in Tender Joint Count 28 (TJC28) |
-2.75; -2.32; -3.06; -4.00; -3.50; -3.65 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168) |
686; 7508 | — |
| SECONDARY Mean Serum Concentrations of Interleukin (IL)-6 by Visit |
15.02; 13.57; 17.24; 158.91; 1.33; 147.37 | — |
| SECONDARY Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit |
37.61; 39.39; 51.03; 237.34; 13.42; 198.39 | — |
| SECONDARY Percentage of Participants With Anti-Tocilizumab Antibody |
7.0; 2.4; 0.0; 2.4 | — |
Summary
This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria
- Disease duration of /= 15 and </= 40 mRSS units at screening
- Active disease, as defined by protocol
- Uninvolved skin at injection sites
- Negative pregnancy test for a female subject of childbearing potential
Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment
- Rheumatic autoimmune disease other than systemic sclerosis
- Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
- Previous treatment with tocilizumab
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Severe cardiopulmonary disease
- Known active current or history of recurrent infections
- Use of any investigational, biologic, or immunosuppressive therapies including intra-articular or parenteral corticosteroids prior to study enrollment as specified in the protocol
- As specified in the protocol, any current or past medical condition or medical history involving but not limited to the nervous, renal, pulmonary, endocrine, and gastrointestinal organ systems determined by the Principal Investigator to pose a significant safety risk to any subject while participating in the study
- Primary or secondary immunodeficiency
Data sourced from ClinicalTrials.gov (NCT01532869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.