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Trial #NCT01584388
Retroperitoneal Fibrosis Clinical Trials

Rituximab in IgG4-related Disease: A Phase 1-2 Trial


Rituximab in IgG4-Related Disease: A Phase 1-2 Trial
Study ID: 2011p002414; Source: Massachusetts General Hospital
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Active, not recruiting
Country n/a
Study type Interventional
Enrollment 30
Start date April 2012
Completion date April 2014
Phase Phase 1/Phase 2
Sponsor Massachusetts General Hospital
Summary:
The primary objective of this study is to evaluate the safety and effectiveness of rituximab
in IgG4-RD.
Description:
This two-center trial will enroll at total of 30 patients with IgG4-RD. The two
participating sites are the Massachusetts General Hospital (Boston, MA) and the Mayo Clinic
(Rochester, MN). All patients will receive rituximab 1 gram intravenously times two doses,
separated by approximately 15 days. The primary efficacy outcome - disease remission and
successful completion of the glucocorticoid taper - will be assessed at six months.
Patients will be followed on the protocol for an additional six months after measurement of
the primary outcome.
Eligibility:
Gender: Both
Age: 18 Years - N/A
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.
Outcome:
Primary outcome
  • Primary (Disease Response)
    Disease Response at six months is the primary endpoint in this trial. The ability to maintain disease remission off glucocorticoids is an important clinical measure in this disease. Disease Response - Disease Response is defined at 6 months as: Improvement of > 2 points in the IgG4-RD RI over baseline No glucocorticoid or other immunosuppressive drug use between months 4 and 6 No disease flares, as assessed by the IgG4-RD Responder Index.
    Time frame: Six months
Contacts:
  • Arezou Khosroshahi, MD; Massachusetts General Hospital (Rheumatology Unit) (Study Director)
  • John H Stone, MD, MPH; Massachusetts General Hospital (Rheumatology Unit) (Study Chair)
Location Country Status
Sponsors:
  • Massachusetts General Hospital - (Lead Sponsor)
  • Genentech, Inc. - Collaborator

Related trials: Terms
  • Orbital pseudotumor
  • Type 1 autoimmune pancreatitis
  • IgG4-related tubulointerstitial nephritis
  • Riedel's thyroiditis
  • Chronic sclerosing sialadenitis
  • Peri-aortitis
  • Retroperitoneal fibrosis
  • Lacrimal glands
  • Aorta
  • Pachymeningitis
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