A randomized controlled phase II, double blinded trial to investigate pulmonary function after treatment with rituximab compared to placebo in patients with Granulomatous Lymphocytic Interstitial Lung Disease

Conditions

Granulomatous Lymphocytic Interstitial Lung Disease (GLILD)

Brief summary

DLCO (expressed in p.p. of predicted DLCO value) at Week 27 (continuous).

Detailed description

DLCO (expressed in p.p. of predicted DLCO value) at baseline, Week 13, 53 and 78 (continuous)., Reaching a 10 p.p. increase in % of predicted DLCO from baseline to Week 27 (dichotomous)., FVC (expressed in p.p. of predicted FVC value) at Week 13, 27, 53 and 78 (continuous)., Reaching a 5 p.p. increase in % of predicted FVC from baseline to Week 27 (dichotomous)., HRCT ILD score at baseline, Week 27 and 53 (continuous)., King’s Brief Interstitial Lung Disease (K-BILD) Questionnaire scores (total and per domain) at baseline and Week 27 (continuous)., Short Form 36 Health Survey (SF-36) scores (total and per domain/concept) at baseline and Week 27 (continuous)., Serum levels of sCD25, sTIM3, BAFF and sBCMA at baseline, Week 13, 27 and 53 (continuous).

Related papers

No related papers found yet.

Interventions

DRUGNatriumklorid Baxter Viaflo 9 mg/ml infusjonsvæske

DRUGoppløsning

DRUGMabThera 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
DLCO (expressed in p.p. of predicted DLCO value) at Week 27 (continuous).	—

Secondary

Measure	Time frame
DLCO (expressed in p.p. of predicted DLCO value) at baseline, Week 13, 53 and 78 (continuous)., Reaching a 10 p.p. increase in % of predicted DLCO from baseline to Week 27 (dichotomous)., FVC (expressed in p.p. of predicted FVC value) at Week 13, 27, 53 and 78 (continuous)., Reaching a 5 p.p. increase in % of predicted FVC from baseline to Week 27 (dichotomous)., HRCT ILD score at baseline, Week 27 and 53 (continuous)., King’s Brief Interstitial Lung Disease (K-BILD) Questionnaire scores (total and per domain) at baseline and Week 27 (continuous)., Short Form 36 Health Survey (SF-36) scores (total and per domain/concept) at baseline and Week 27 (continuous)., Serum levels of sCD25, sTIM3, BAFF and sBCMA at baseline, Week 13, 27 and 53 (continuous).	—

Measure

Time frame

DLCO (expressed in p.p. of predicted DLCO value) at baseline, Week 13, 53 and 78 (continuous)., Reaching a 10 p.p. increase in % of predicted DLCO from baseline to Week 27 (dichotomous)., FVC (expressed in p.p. of predicted FVC value) at Week 13, 27, 53 and 78 (continuous)., Reaching a 5 p.p. increase in % of predicted FVC from baseline to Week 27 (dichotomous)., HRCT ILD score at baseline, Week 27 and 53 (continuous)., King’s Brief Interstitial Lung Disease (K-BILD) Questionnaire scores (total and per domain) at baseline and Week 27 (continuous)., Short Form 36 Health Survey (SF-36) scores (total and per domain/concept) at baseline and Week 27 (continuous)., Serum levels of sCD25, sTIM3, BAFF and sBCMA at baseline, Week 13, 27 and 53 (continuous).

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Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed