Rituximab in Systemic Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-09

Study Completion Date

2016-04-18

Brief Summary

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The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis

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Detailed Description

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Systemic sclerosis (SSc) is a rare disease, characterized by microvascular and immunological changes promoting extra-cellular matrix synthesis and widespread fibrosis. No treatment has yet proven any ability to alter the disease fibrosing process. Specific auto-antibodies are commonly found in this disease, and B lymphocytes are detected in cutaneous and pulmonary infiltrates. Studies derived from murine models suggest a role for B lymphocyte blocking strategies.

This lead to observational trials of B-cell therapy using rituximab in SSc that provided encouraging results with no particular signal concerning tolerability. These trials included heterogeneous patients with variable disease stages and different involved organs, and were mostly unblinded, which preclude any definitive conclusion. However, they support the continuous development of this therapeutic approach.

Taking up the early phase of the diffuse form of the disease is complicated by its rarity and the heterogeneous progression of its visceral complications. This raises the question of selecting a homogeneous group of patients to evaluate. The most convincing results for the use of rituximab in autoimmune conditions have been found in rheumatoid arthritis. Joint involvement is common in SSc with 75% of patients complaining about joint stiffness and pain, and 30% presenting with synovitis, tenosynovitis, or flexion contractures. No specific treatment has already addressed this issue, and it is generally proposed to use small doses of oral corticosteroids in association with methotrexate, by analogy with rheumatoid arthritis. We propose to evaluate the efficacy and safety of rituximab in SSc patients having active arthritis despite first line treatment. Improving the articular involvement would improve the quality of life f SSc patients and effectiveness of rituximab on skin and lung fibrotic involvements will be assessed as secondary outcomes to estimate the overall effects of this drug on SSc.

Conditions

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Systemic Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NaCl

NaCl 500 ml IV day 1 and day 15 plus 100 mg methylprednisolone

Group Type PLACEBO_COMPARATOR

Placebo (NaCl)

Intervention Type DRUG

Days 1 and 15, NaCl 500 ml plus 100 mg methylprednisolone

Rituximab

Rituximab 1G IV day 1 and day 15 plus 100 mg methylprednisolone

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

Days 1 and 15, rituximab 1 gramme plus 100 mg methylprednisolone

Interventions

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Rituximab

Days 1 and 15, rituximab 1 gramme plus 100 mg methylprednisolone

Intervention Type DRUG

Placebo (NaCl)

Days 1 and 15, NaCl 500 ml plus 100 mg methylprednisolone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Systemic sclerosis fulfilling ACR or LeRoy's criteria
* Active polyarthritis defined by \> 6/53 tender joints and \> 4/53 swollen joints
* Ongoing first line therapy by prednisone (max 10 mg/d) and DMARDS (methotrexate, leflunomide, azathioprine or mycophenolate)
* Birth control if applicable

Exclusion Criteria

* Past therapy with Rituximab.
* Severe and uncontrolled disease with renal, liver or haematological (neutropenia \< 1500 / mm3) failures, pulmonary (FVC \< 50%) or cardiac insufficiencies (LVEF \< 50%)
* Not stable corticosteroid therapy or cyclophosphamide use in the last 6 months
* Infectious risk : viral infections by B or C hepatitis or HIV, hypogammaglobulinemia (\< 6 G/L), opportunistic infection or infection requiring IV antibiotics in the last 3 months.
* Neoplastic solid tumor in the last 5 years
* Drug or alcool abuses
* Receiving patient or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No