Treatment of Granulomatous and Lymphocytic Interstitial Lung Disease in Patients With Common Variable Immunodeficiency

Conditions

• Granulomatous and Lymphocytic Interstitial Lung Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab (RTX) and Azathioprine (AZA) — DRUG
  Rituximab 375 mg/m2/dose IV over 4 hours first dose, IV over 2-3 hours each subsequent dose weekly for 4 weeks at enrollment and again at months 6 and 12 for the active comparator arm Rituximab (RTX) and Azathioprine (AZA).
• Placebos — DRUG
  IV placebo will be administered on the same schedule as Rituximab and oral placebo will be administered by mouth daily for 18 months.

Study Details

This phase II study will assess the effect of a treatment combination of Rituximab and azathioprine in patients with Granulomatous and Lymphocytic Interstitial Lung Disease (GLILD) compared to placebo, based on change in lung function at 18 months compared to baseline. The researchers will also assess if the drugs improved quality of life.

Key Dates

Start date

May 2, 2016

Status verified

Mar 2020

Primary completion

Mar 6, 2018

Completion

Mar 6, 2018

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Rituximab (RTX) and Azathioprine (AZA)
  Rituximab 375 mg/m2/dose IV over 4 hours first dose, IV over 2-3 hours each subsequent dose weekly for 4 weeks at enrollment and again at months 6 and 12. Azathioprine: Starting dose of azathioprine will be 50 mg and increased in 25 mg increments to a maximum dose of 150 mg or 2 mg/k/day (whichever is lowest) as tolerated. Azathioprine will be administered by mouth daily for 18 months.
• Placebo Comparator: Placebo
  IV placebo will be administered on the same schedule as Rituximab. Oral placebo will be administered by mouth daily for 18 months.

Primary Outcome Measure

The effect of treatment with RTX/AZA in patients with GLILD compared to placebo, based on change in forced vital capacity (FVC) at 18 months compared to baseline. [ Time Frame: Baseline and 18 months ]