The goal of this clinical trial is to evaluate the efficacy on lung function after 24 weeks of rituximab + MMF combination comparatively to placebo + MMF combination in patients with SSc-ILD severe at the initial assessment or at high risk of progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
102
one course of IV rituximab consisting of an infusion of 1000 mg rituximab (diluted in 500 mL of saline 0.9 % sodium chloride) will be given at day 1, day 15 and an infusion of 500 mg rituximab (in 500 mL of saline 0.9 % sodium chloride) at week 24;
one course of intravenous placebo of rituximab consisting of an infusion of 500 mL of saline (0.9% sodium chloride) infusion will be given at day 1, day 15 and week 24;
Forced vital Capacity in %
The primary outcome is the change in Forced Vital Capacity (FVC) (in % predicted) from baseline to week 24 with measures at baseline, week 12 and week 24.
Time frame: At 24 weeks
Forced Vital Capacity in %
Change in % of predicted FVC (% FVC)
Time frame: From baseline to weeks 48
Forced Vital Capacity in mL
Change in FVC (mL)
Time frame: From baseline to weeks 24 and 48
Rodnan skin score
Change in modified Rodnan skin score (mRSS). This score assesses the extent of thickening at 17 points on the body, simply by palpating the skin. Thickening is from 0 to 3. 0 equals to normal skin thickness and 3 to severe thickening.
Time frame: From baseline to weeks 24 and 48
Progression free survival
First event considered
Time frame: At 24 and 48 weeks
Overall survival
Time frame: At 48 weeks
Scleroderma Health Assessment questionnaire
23 questions divided into four groups related to symptoms of vascular, respiratory, gastrointestinal and musculoskeletal dysfunction
Time frame: From baseline to weeks 24 and 48
King's Brief Interstitial Lung Disease questionnaire
15 questions about the impact of the disease on life. All answers are from 1 to 7. There is no maximum and minimum.
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Time frame: From baseline to weeks 24 and 48
Living with pulmonary fibrosis symptom questionnaire
23 questions to evaluate symptoms of pulmonary fibrosis
Time frame: From baseline to weeks 24 and 48
Living with pulmonary fibrosis impact questionnaire
21 questions to determine how pulmonary fibrosis affects quality of life.
Time frame: From baseline to weeks 24 and 48
Diffusing capacity for carbon monoxide
Changes in % of predicted diffusing capacity for carbon monoxide
Time frame: From baseline to weeks 24 and 48
6 minutes walk test
Changes in the 6 minute walk test
Time frame: From baseline to weeks 24 and 48
Physical activity
Change in accelerometer-assessed physical activity based on the number of steps per day
Time frame: From baseline to week 24
Physical activity
Change in accelerometer-assessed physical activity based on heart rate
Time frame: From baseline to week 24
Chest image
Changes in HRCT chest images will be assessed by two thoracic radiologists expert in ILDs, who will score the extent of ILD and the severity of traction bronchiectasis. The ILD extent score will be estimated to the nearest 10% at three lung zones (delimited by the carina and the lowest inferior pulmonary vein for both lungs) and averaged between these 3 zones. Traction bronchiectasis scores will be scored between 0 and 3 (0=absence; 1=mild dilatation without tortuosity; 2=moderate dilatation, \< 6mm diameter, with tortuosity; 3=severe dilatation≥ 6mm) for the same three lung zones and averaged for the whole lungs.
Time frame: From baseline to week 48
Biological markers
Changes of biological markers related to B-cell depletion. Change in the number of CD19 lymphocytes in absolute value/liter
Time frame: From baseline to week 48
Biological markers
Changes of biological markers related to B-cell depletion. Change in the number of CD19 lymphocytes in percentage of leukocytes
Time frame: From baseline to week 48
Biological markers
Changes of biological markers related to B-cell depletion. Change in serum gamma globulin concentration in grams/liter
Time frame: From baseline to week 48
Biological markers
Changes of biological markers related to B-cell depletion. Change in serum gamma globulin concentration as a percentage of serum proteins
Time frame: From baseline to week 48
Advers events
Analyze of all adverse events, especially serious infectious adverse events, occurring during treatment period
Time frame: From baseline to week 48
Pharmacokinetic
Pharmacokinetic parameters of rituximab : volume of distribution in liter
Time frame: At Day 1, day 15, week 12, week 24 and week 48
Pharmacokinetic
Pharmacokinetic parameters of rituximab : clearance in mili liter per minute
Time frame: At Day 1, day 15, week 12, week 24 and week 48
Pharmacokinetic
Pharmacokinetic parameters of rituximab : half life in secondes
Time frame: At Day 1, day 15, week 12, week 24 and week 48
Cumulative doses of corticosteroids
Time frame: At week 24 and week 48