Rituximab in Interstitial Pneumonitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This project will address rare immune mediated inflammatory diseases (IMIDs) involving the lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary study parameter is pulmonary function.

The secondary objectives are to explore the application of imaging with radiolabeled RTX as early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical markers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Efficacy and Safety of Rituximab With Mycophenolate Mofetil in Patients With Interstitial Lung Diseases

NCT02990286

Lung Disease, Interstitial

COMPLETED PHASE3

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

NCT02789397

Granulomatous and Lymphocytic Interstitial Lung Disease

WITHDRAWN PHASE2

Rituximab Therapy in Patients With Treatment Refractory Hypersenstivity Pneumonitis

NCT07035561

Hypersenstivity Pneumonitis ILD

COMPLETED PHASE2

An Open Label Pilot Study Examining the Use of Rituximab in Patients With Wegener's Granulomatosis Who Have Experienced Disease Relapse on Standard Therapies

NCT00072592

Wegener's Granulomatosis

COMPLETED PHASE1

Anti-CD3 & Anti-CD7 Ricin A Immunotoxin-Combination for Acute Graft Versus Host Disease

NCT00640497

Acute Graft Versus Host Disease

WITHDRAWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Diseases, Interstitial Pneumonitis, Interstitial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

rituximab

single arm study with Zr-89-rituximab immuno PET/CT

Group Type OTHER

Rituximab

Intervention Type DRUG

2 times 1000mg dose at 14 days interval treatment

Zr-89-rituximab immuno PET/CT

Intervention Type RADIATION

Immuno labeled PET/CT of the lungs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rituximab

2 times 1000mg dose at 14 days interval treatment

Intervention Type DRUG

Zr-89-rituximab immuno PET/CT

Immuno labeled PET/CT of the lungs

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Immuno PET

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

In order to be eligible to participate in the study, subjects must meet all of the following criteria:

* Age 18 to 70 years
* No previous therapy with rituximab
* At least 2 pulmonary function tests within past 6 months
* Diagnosis of co-existing IMID and a severe and / or progressive IP characterized by 3 out of the following items:
* Respiratory symptoms consistent with interstitial lung disease
* Diagnosis of usual interstitial pneumonia (UIP), non-specific interstitial pneumonia (NSIP), organizing pneumonia (OP) or a mixed form of UIP / NSIP / OP by either of the following:
* Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP / NSIP / OP
* High Resolution Computer Tomography (HRCT) scan showing definite or probable UIP/NSIP/OP/mixed
* Forced Vital Capacity (FVC) \< 50% predicted and/or diffusing capacity of the lung for carbon monoxide (DLCO) \< 40% predicted or worsening of lung function as demonstrated by any one of the following within the past year:
* \> 10% decrease in FVC
* \> 15% decrease in DLCO
* Therapy resistance to 1st (corticosteroids) and 2nd line therapy(cyclophosphamide or azathioprine)

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Residual volume \>120% predicted at screening
* DLCO \<25% of predicted value at screening + resting Oxygen Saturation (SAO2) without external oxygen \<90%
* History of unstable or deteriorating cardiac or neurological disease
* Pregnancy or lactation
* Hematology lower than specified limits (leucocytes)
* Positive HIV, hepatitis B or C serology
* Pre-existing conditions which lead to a life expectancy of less than 6 months
* Receipt of any vaccine, particularly live viral vaccines, within 4 weeks before first rituximab dose
* Hypersensitivity for murine proteins

NOTE:

* Fever (\>37,9 °C) at presentation is reason to delay therapy by 1 week
* Evidence of active infection is reason to postpone rituximab treatment until no further signs of active infection
* Severe renal impairment is not a contraindication for rituximab therapy, however, if patients (might) require dialysis frequently they will be excluded from the study group

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No