Rituximab in Systemic Sclerosis

NCT01748084 | Completed Phase 2 DMC

• 2 other identifiers: P1101102012-001636-56
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis; Arthritis; B-cell therapy, Anti-CD20 therapy; Quality of life; Scleroderma; Lung fibrosis; Randomised controled trial

Outcome Measures

Primary Outcomes (1)

• Number of tender and swollen joints

  Measured out of 53 joints

  at 6 months

Secondary Outcomes (5)

• Quality of life: SSc-HAQ

  at 6 and 12 months

• Scleroderma

  at 6 and 12 months

• Lung fibrosis

  at 6 and 12 months

• Quality of life: SF-36

  at 6 and 12 months

• Quality of life: Duruöz index

  at 6 and 12 months

Study Arms (2)

NaCl

PLACEBO COMPARATOR

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

Drug: Placebo (NaCl)

Rituximab

EXPERIMENTAL

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

Drug: Rituximab

Interventions

Rituximab DRUG

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

Rituximab

Placebo (NaCl) DRUG

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

NaCl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (5)

• Bosello S, De Santis M, Lama G, Spano C, Angelucci C, Tolusso B, Sica G, Ferraccioli G. B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial. Arthritis Res Ther. 2010;12(2):R54. doi: 10.1186/ar2965. Epub 2010 Mar 25.

  PMID: 20338043 BACKGROUND

• Simms RW, Lafyatis R. Rituximab: a potential therapeutic advance in scleroderma: what is the evidence? Rheumatology (Oxford). 2010 Feb;49(2):201-2. doi: 10.1093/rheumatology/kep421. Epub 2009 Dec 23. No abstract available.

  PMID: 20032221 BACKGROUND

• Daoussis D, Liossis SN, Tsamandas AC, Kalogeropoulou C, Kazantzi A, Korfiatis P, Yiannopoulos G, Andonopoulos AP. Is there a role for B-cell depletion as therapy for scleroderma? A case report and review of the literature. Semin Arthritis Rheum. 2010 Oct;40(2):127-36. doi: 10.1016/j.semarthrit.2009.09.003. Epub 2009 Dec 11.

  PMID: 20004954 BACKGROUND

• Daoussis D, Liossis SN, Tsamandas AC, Kalogeropoulou C, Kazantzi A, Sirinian C, Karampetsou M, Yiannopoulos G, Andonopoulos AP. Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study. Rheumatology (Oxford). 2010 Feb;49(2):271-80. doi: 10.1093/rheumatology/kep093. Epub 2009 May 15.

  PMID: 19447770 BACKGROUND

• Lafyatis R, Kissin E, York M, Farina G, Viger K, Fritzler MJ, Merkel PA, Simms RW. B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis. Arthritis Rheum. 2009 Feb;60(2):578-83. doi: 10.1002/art.24249.

  PMID: 19180481 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic; Arthritis; Scleroderma, Diffuse; Pulmonary Fibrosis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yannick Allanore, MD, PhD

  Assistance Publique Hôpitaux de Paris, Université Paris Descartes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: April 9, 2013
• Primary Completion: April 18, 2016
• Study Completion: April 18, 2016
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)