Use of Azithromycin as Immunomodulatory Therapy in Grave's Orbitopathy
| Tracking Information | |||||
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| First Received Date ICMJE | May 11, 2011 | ||||
| Last Updated Date | June 22, 2011 | ||||
| Start Date ICMJE | May 2011 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in clinical activity score between baseline and after three months [ Time Frame: Three months ] [ Designated as safety issue: No ] Change in the clinical activity score between baseline and after 3 months (Clinical Activity Score is a validated index of Graves Ophthalmopathy that assigns one point to the presence of: 1.spontaneous retrobulbar pain, 2. pain on up/downgaze, 3. redness of eyelids, 4. redness of conjunctiva, 5. swelling of eyelids, 6. inflammation of caruncle/plica, 7. chemosis). The maximal clinical activity score is thus 7. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01379196 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of Azithromycin as Immunomodulatory Therapy in Grave's Orbitopathy | ||||
| Official Title ICMJE | Use of Azithromycin as Immunomodulatory Therapy in Grave's Orbitopathy | ||||
| Brief Summary | The purpose of this study is to examine the effects of Azithromycin (a macrolide class antibiotic), given three times weekly, for patients with active moderate-severe, non sight-threatening, Graves Orbitopathy. Indices for follow-up will include:
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| Detailed Description | Graves Orbitopathy (GO) is an autoimmune inflammatory disorder causing visual morbidity, cosmetic morbidity and interference with quality of life. The disease has an inflammatory stage and a non-inflammatory, fibrotic stage. Treatment of inflammatory stage moderate-severe GO includes steroids, as recommended by the EUGOGO consortium. However, the length of treatment needed and the risk of steroid side-effects may lead to multiple undesired treatment induced morbidity. Antibiotics of the macrolide group posses known immune-modulatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of macrolide antibiotics for delaying graft rejection following lung transplants. We propose to test the effect of this class of antibiotics for non-sight threatening, moderate-severe, inflammatory GO. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Graves Ophthalmopathy | ||||
| Intervention ICMJE | Drug: Azithromycin
Tab. Azithromycin 500 mg PO three times weekly for 3 months |
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| Study Arm (s) | Experimental: Azithromycin PO three times weekly
Tablets Azithromycin 500 mg PO three times weekly for three months
Intervention: Drug: Azithromycin |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 14 | ||||
| Estimated Completion Date | November 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01379196 | ||||
| Other Study ID Numbers ICMJE | 0427-10-RMC | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Hadas Stiebel-Kalish, MD, Chief, Neuro-Ophthalmology Unit,, Rabin Medical Center, Petah Tikva 49100, Israel | ||||
| Study Sponsor ICMJE | Rabin Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rabin Medical Center | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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