Rituximab in Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01748084
• Date of registration: 10/12/2012
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Rituximab in Systemic Sclerosis RECOVER
• Scientific title: Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis
• Date of first enrolment: April 9, 2013
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01748084
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Yannick Allanore, MD, PhD
• Affiliation: Assistance Publique Hôpitaux de Paris, Université Paris Descartes

Key inclusion & exclusion criteria

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:

- Overlap syndrome defined by clinical symptoms and positive specific auto-antibodies
(anti-CCP, anti-SSA, anti-DNA DNA anti-Sm) (Rheumatoid factors and anti-RNP are not
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)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: Rituximab

Drug: Placebo (NaCl)

Primary Outcome(s)

Number of tender and swollen joints [Time Frame: at 6 months]

Secondary Outcome(s)

Quality of life: Duruöz index [Time Frame: at 6 and 12 months]

Quality of life: SSc-HAQ [Time Frame: at 6 and 12 months]

Lung fibrosis [Time Frame: at 6 and 12 months]

Scleroderma [Time Frame: at 6 and 12 months]

Quality of life: SF-36 [Time Frame: at 6 and 12 months]

Secondary ID(s)

2012-001636-56

P110110

Source(s) of Monetary Support

Please refer to primary and secondary sponsors