Clinical Trial: Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy: a Prospective, Uncontrolled Pilot Study
Brief Summary: The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy (GO).
Detailed Summary:
Graves'orbitopathy is an autoimmune disease characterised by an inflammatory phase followed by fibrosis. Surgery to correct eyelid swelling, proptosis, and diplopia is effective, but can not be done until the inflammatory phase has passed. To arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. Corticosteroids are the first-choice immunosuppressive treatment, but they often cause severe side-effects.
Subantimicrobial dose doxycycline posses known anti-inflammatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of subantimicrobial dose doxycycline for rosacea, periodontitis and multiple sclerosis.
We propose to test the effect of subantimicrobial dose doxycycline for non-sight threatening, moderate-severe, inflammatory GO.
Sponsor: Sun Yat-sen University
Current Primary Outcome: • Treatment response [ Time Frame: 24 weeks ]
Original Primary Outcome: • European Group on Graves' Orbitopathy (EUGOGO) Clinical Activity Score [ Time Frame: Primary study measures - 6 months ]
Current Secondary Outcome:
- Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 24 weeks ]
- Graves' orbitopathy-Specific Quality of Life (GO-QoL) [ Time Frame: 24 weeks ]
Original Secondary Outcome: • Health related quality of life questionnaires (GO-QoL) [ Time Frame: Primary study measures - 6 months ]
Information By: Sun Yat-sen University
Dates:
Date Received: November 12, 2012
Date Started: October 2012
Date Completion:
Last Updated: December 7, 2013
Last Verified: December 2013