Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT02981082|
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis Pulmonary; Hypertension||Drug: Dimethyl Fumarate (DMF) Drug: Placebo Oral Tablet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||May 2020|
Active Comparator: Dimethyl Fumarate (DMF)
Twice daily oral doses of Dimethyl Fumarate (DMF) 120mg for the first 7 days followed by the maintenance dose of Dimethyl Fumarate (DMF) 240mg twice a day. Subjects will be dosed for 24 weeks
Drug: Dimethyl Fumarate (DMF)
Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis.
Other Name: Tecfidera
Placebo Comparator: Placebo
Twice daily oral doses of placebo for 12 weeks
Drug: Placebo Oral Tablet
Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)
- 6 minute walk distance (6MWD). [ Time Frame: Baseline to Week 24 ]The primary outcome of clinical efficacy in this study will be improvement in 6‐minute walk distance (6MWD).
- Clinical Worsening [ Time Frame: Baseline to Week 24 ]The change in time to clinical worsening in DMF compared to placebo treated patients.
- Borg Dyspnea Index (BDI) [ Time Frame: Baseline to Week 24 ]The change in Borg Dyspnea Index (BDI) at 24 weeks from baseline in DMF compared to placebo treated patients
- Serum markers of oxidative stress [ Time Frame: Baseline to Week 24 ]The change from baseline of serum markers of oxidative stress at 24 weeks, comparing DMF to placebo treated patients.
- Proteomic biomarkers [ Time Frame: Baseline to Week 24 ]The change from baseline in proteomic biomarkers, including BNP, at 24 weeks, comparing DMF to placebo treated patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981082
|Contact: Robert A Lafyatis, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Maureen M Laffoon, BS 412-648-7871 email@example.com|
|Contact: Dana Ivanco, EMT 412-648-7040 firstname.lastname@example.org|
|Principal Investigator: Robert A Lafyatis, MD|
|Principal Investigator:||Robert A Lafyatis, MD||University of Pittsburgh|