Study of Therapeutic Plasma Exchange, Rituximab, and Intravenous Immunoglobulin for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)
University of Alabama at Birmingham
Summary
This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF).
Description
Patients with progressive pulmonary fibrosis, identified at any of nine participating leading U.S. medical centers, will be randomized (by computer) in a 1:1 ratio to either AART or treatment as usual (TAU). Stratification factors for randomization are sex (self-identified) and whether or not patients are taking any IPF-approved medication. Patients will be observed for six (6) months, with observations and assessments made at baseline, 30 days after randomization, and 90 and 180 days after randomization. Data will be electronically submitted via electronic case report forms (eCRF) to a Data…
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age between 40-85 years old. 2. A diagnosis of IPF that fulfills latest ATS/ERS Consensus Criteria. 3. A diagnosis of Progressive IPF (P-IPF), defined as a relative decrease of FVC%p \>10% during the preceding twelve months, and substantiated by replicate values at least three weeks apart. 4. Ability and willingness to give informed consent (no surrogates) and adhere to requirements. 5. Have eligibility confirmed by a consensus of trial investigators. 6. Is not now or has been in experimental regimen for at least 2 weeks (or 5 half-lives of agent) and agrees to not beco…