World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
Note: This record shows only 24 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01584388
Date of registration: 22/04/2012
Prospective Registration: No
Primary sponsor: Massachusetts General Hospital
Public title: Rituximab in IgG4-RD: A Phase 1-2 Trial
Scientific title: Rituximab (RTX) for IgG4-related Disease (IgG4-RD): a Prospective,Open-label Trial
Date of first enrolment: April 2012
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01584388
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Contact type:
Name:     Arezou Khosroshahi, MD
Address: 
Telephone:
Email:
Affiliation:  Massachusetts General Hospital (Rheumatology Unit)
Contact type:
Name:     John H Stone, MD, MPH
Address: 
Telephone:
Email:
Affiliation:  Massachusetts General Hospital (Rheumatology Unit)
Key inclusion & exclusion criteria

Inclusion Criteria:

Patients will be included in the trial based on the following disease-specific criteria:

- Age 18 or older

- Diagnosis of IgG4-RD, based upon either pathological criteria* (for those who have
undergone biopsies) or clinical criteria.** The criteria for pathological and clinical
diagnoses are specified below.

- The subject can be either steroid-naive, in relapse, steroid dependent, or
refractory to steroids. Subjects who are steroid dependent or refractory are
eligible for enrollment if steroid dose has not been increased in the past 2
weeks, and their treating physician plans to withdraw steroids completely (by
dose taper) within 8 weeks of starting rituximab.

- Pathological diagnosis:

- Histopathologic features consisting of a lymphoplasmacytic infiltrate
and storiform fibrosis within involved organs. Other histopathologic
features consistent with IgG4-RD (e.g., obliterative phlebitis) may be
present but are not required.

- Either an IgG4/IgG plasma cell ratio of > 50% within the affected
organs or more than 10 IgG4-bearing plasma cells per high-power field.

All patients with pathologic diagnoses will have their specimens reviewed by pathology
investigators.

**Clinical diagnosis:

• Organ involvement in a pattern consistent with IgG4-RD. This must include dysfunction of
one of the following organs: pancreas (autoimmune pancreatitis); salivary glands (chronic
sclerosing sialadenitis); lacrimal glands; orbital pseudotumor; kidneys; lungs; lymph
nodes; meninges; aorta (including aortitis/periaortitis and/or retroperitoneal fibrosis);
thyroid gland (Riedel's thyroiditis). If a patient is enrolled with a clinical diagnosis
alone, the diagnosis must be accompanied by both an imaging finding compatible with IgG4-RD
and a 1.5-fold elevation in the serum IgG4 concentration.

Exclusion Criteria:

Patients will be excluded from the study based on the following criteria:

Disease-Specific Concerns: Excessive fibrosis within organs, such that a disease response
to rituximab would not be expected.

General Medical Concerns:

- Pregnancy (a negative serum pregnancy test should be performed for all women of
childbearing potential within 7 days of treatment), or lactating.

- Inability to comply with study and/or follow-up procedures.

Rituximab-Specific Concerns:

- History of HIV.

- Presence of active infection.

- New York Heart Association Classification III or IV heart disease (See Appendix D).

- Concomitant malignancies or previous malignancies within the last five years, with the
exception of adequately treated basal or squamous cell carcinoma of the skin or
carcinoma in situ of the cervix.

- At the Investigator's discretion, receipt of a live vaccine within 4 weeks prior to
randomization.

- Positive hepatitis B or C serology is considered a potential exclusion criterion.
Hepatitis B screening should include hepatitis B antibody and surface antigen for a
patient with no risk factors. For patients with risk factors or previous history of
hepatitis B, add core antibodies and e-antigen.

- Allergies: History of severe allergic reactions to human or chimeric monoclonal
antibodies or murine protein.

- Uncontrolled disease: They show evidence of other uncontrolled disease, including drug
and alcohol abuse, which that could interfere with participation in the trial
according to the protocol.

- History of anti-human anti-chimeric antibody formation.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Sialadenitis
Retroperitoneal Fibrosis
Autoimmune Pancreatitis
Pseudotumor
Intervention(s)
Drug: Rituximab
Primary Outcome(s)
No Disease Flares During Rituximab Treatment Phase [Time Frame: Month 6]
IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment [Time Frame: 6 months]
Cumulative Glucocorticoid Use at Baseline and 6 Months [Time Frame: 6 months]
Secondary Outcome(s)
Complete Remission [Time Frame: 6 months]
Disease Response at 6 Months [Time Frame: 6 months]
Retreatment With Rituximab for Disease Relapse [Time Frame: 12 months]
Sustained Disease Response [Time Frame: 12 months]
Time to Relapse [Time Frame: Days]
Complete Remission at Any Timepoint [Time Frame: 12 months]
Complete Remission (Any Timepoint), Exclusive of Serum IgG4 [Time Frame: 12 months]
Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months. [Time Frame: 6 months]
Time to Complete Remission [Time Frame: Days]
Time to Disease Response [Time Frame: Mean days +/- standard deviation]
Secondary ID(s)
2011p002414
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Genentech, Inc.
Ethics review
Results
Results available: Yes
URL: https://clinicaltrials.gov/ct2/show/results/NCT01584388
URL of the protocol:
Date Posted: 02/07/2017
Date of completion:
Date of first publication:
Results summary:
Baseline characteristics:
Adverse events:
Outcome measures:
IPD sharing plan:
IPD sharing description:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey