Khanna, D;
Tashkin, DP;
Wells, AU;
Seibold, JR;
Wax, S;
Vazquez-Mateo, C;
Fleuranceau-Morel, P;
... Denton, CP; + view all
(2021)
STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease.
The Journal of Rheumatology
, 48
(8)
pp. 1295-1298.
10.3899/jrheum.191365.
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Abstract
OBJECTIVE: To investigate the effects of abituzumab in systemic sclerosis-associated interstitial lung disease (SSc-ILD). METHODS: STRATUS was a Phase II, double-blind, parallel-group, multicenter trial (NCT02745145). Adults (≤75 years) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, placebo, or abituzumab 500 mg every 4 weeks for 104 weeks. Primary endpoint: annual rate of change in absolute FVC. RESULTS: STRATUS was terminated prematurely due to slow enrolment (n=75 screened, n=24 randomized), precluding robust analysis of efficacy. Abituzumab was well-tolerated; no new safety signals were detected. CONCLUSION: Further investigation of abituzumab for treatment of SSc-ILD is required.
| Type: | Article |
|---|---|
| Title: | STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease |
| Location: | Canada |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.3899/jrheum.191365 |
| Publisher version: | https://doi.org/10.3899/jrheum.191365 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | clinical trial, integrins, interstitial lung disease, systemic sclerosis |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10111583 |
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