Systemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000224-27-GB

Enrollment

Registered

2008-08-07

Start date

2008-10-15

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis associated interstitial lung disease MedDRA version: 9.1 Level: LLT Classification code 10042953 Term: Systemic sclerosis

Interventions

Trade Name: Solu-medrone Product Name: methylprednisolone Pharmaceutical Form: Intravenous infusion INN or Proposed INN: METHYLPREDNISOLONE CAS Number: 83432 Current Sponsor code: MP Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Fulfill 1980 ACR preliminary classification criteria for SSc Age >18 yrs Presence of HRCT evidence of any ground glass opacification as a marker of alveolitis or other changes consistent with ILD Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Persistent microscopic haematuria Persistent leucopenia (neutrophil count <1.5 x 10 9 /l) or thrombocytopenia (<140 x 10 9/l) Pregnant or breast feeding or absence of contraception Active chronic infection in lung or elsewhere

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the change in lung function (DLCO, FVC and HRCT lung scan), skin thickness, skin fluorescence, tissue perfusion, functional and health-related quality of life measures, Raynaud’s phenomenon and digital ulceration, renal disease and musculoskeletal disease in a comprehensively studied prospective cohort of patients with newly diagnosed SSc beginning treatment with intravenous methylprednisolone and intravenous cyclophosphamide as per the protocol from 2008 versus newly diagnosed patients with SSc but not treated with intravenous methylprednisolone and cyclophosphamide (through patient choice) to identify predictors of response. ;Secondary Objective: Secondary aims: To determine the mortality rate in patients with SSc and interstitial lung disease who have received treatment with intravenous methylprednisolone and intravenous cyclophosphamide versus patients with SSc and lung involvement who have not received intravenous methylprednisolone and intravenous cyclophosphamide versus the mortality rate in patients with SSc but no interstitial lung involvement. To compare the difference in response to treatment between those with diffuse systemic sclerosis and those with limited systemic sclerosis particularly with regards to skin disease. To compare 12 month and two year outcomes of this dose-escalated cohort with data from a previous cohort using a fixed dose regimen of intravenous methylprednisolone and cyclophosphamide. ;Primary end point(s): Primary outcome measures: Change in % predicted FVC and DLCO Secondary outcome measures: Change in dyspnoea index (Mahler Dyspnoea Index), lung HRCT scan scores, modified Rodnan Skin Score, ultrasound skin thickness, scleroderma health assessment questionnaire (SHAQ), short form 36 (SF-36), St George's Respiratory Questionnaire	—

Measure

Time frame

Main Objective: To assess the change in lung function (DLCO, FVC and HRCT lung scan), skin thickness, skin fluorescence, tissue perfusion, functional and health-related quality of life measures, Raynaud’s phenomenon and digital ulceration, renal disease and musculoskeletal disease in a comprehensively studied prospective cohort of patients with newly diagnosed SSc beginning treatment with intravenous methylprednisolone and intravenous cyclophosphamide as per the protocol from 2008 versus newly diagnosed patients with SSc but not treated with intravenous methylprednisolone and cyclophosphamide (through patient choice) to identify predictors of response. ;Secondary Objective: Secondary aims: To determine the mortality rate in patients with SSc and interstitial lung disease who have received treatment with intravenous methylprednisolone and intravenous cyclophosphamide versus patients with SSc and lung involvement who have not received intravenous methylprednisolone and intravenous cyclophosphamide versus the mortality rate in patients with SSc but no interstitial lung involvement. To compare the difference in response to treatment between those with diffuse systemic sclerosis and those with limited systemic sclerosis particularly with regards to skin disease. To compare 12 month and two year outcomes of this dose-escalated cohort with data from a previous cohort using a fixed dose regimen of intravenous methylprednisolone and cyclophosphamide. ;Primary end point(s): Primary outcome measures: Change in % predicted FVC and DLCO Secondary outcome measures: Change in dyspnoea index (Mahler Dyspnoea Index), lung HRCT scan scores, modified Rodnan Skin Score, ultrasound skin thickness, scleroderma health assessment questionnaire (SHAQ), short form 36 (SF-36), St George's Respiratory Questionnaire

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026