Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT01584388 |
Date of registration:
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22/04/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Rituximab in IgG4-RD: A Phase 1-2 Trial
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Scientific title:
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Rituximab (RTX) for IgG4-related Disease (IgG4-RD): a Prospective,Open-label Trial |
Date of first enrolment:
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April 2012 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01584388 |
Study type:
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Interventional |
Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Contact type:
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Name:
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Arezou Khosroshahi, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital (Rheumatology Unit) |
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Contact type:
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Name:
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John H Stone, MD, MPH |
Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital (Rheumatology Unit) |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Sialadenitis
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Retroperitoneal Fibrosis
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Autoimmune Pancreatitis
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Pseudotumor
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Intervention(s)
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Drug: Rituximab
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Primary Outcome(s)
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No Disease Flares During Rituximab Treatment Phase
[Time Frame: Month 6]
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IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment
[Time Frame: 6 months]
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Cumulative Glucocorticoid Use at Baseline and 6 Months
[Time Frame: 6 months]
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Secondary Outcome(s)
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Complete Remission
[Time Frame: 6 months]
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Disease Response at 6 Months
[Time Frame: 6 months]
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Retreatment With Rituximab for Disease Relapse
[Time Frame: 12 months]
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Sustained Disease Response
[Time Frame: 12 months]
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Time to Relapse
[Time Frame: Days]
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Complete Remission at Any Timepoint
[Time Frame: 12 months]
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Complete Remission (Any Timepoint), Exclusive of Serum IgG4
[Time Frame: 12 months]
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Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months.
[Time Frame: 6 months]
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Time to Complete Remission
[Time Frame: Days]
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Time to Disease Response
[Time Frame: Mean days +/- standard deviation]
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Secondary ID(s)
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2011p002414
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available: |
Yes |
URL: |
https://clinicaltrials.gov/ct2/show/results/NCT01584388
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URL of the protocol: |
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Date Posted: |
02/07/2017 |
Date of completion: |
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Date of first publication: |
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Results summary: |
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Baseline characteristics: |
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Adverse events: |
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Outcome measures: |
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IPD sharing plan: |
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IPD sharing description: |
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