Myasthenia Gravis Clinical Trial
— MYACOROfficial title:
Comparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter Study
Verified date | October 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pathology - Generalized myasthenia gravis (MG) is cause of muscle weakness that can have a
significant impact on daily life activity but can also be, when respiratory or bulbar muscles
are involved, life-threatening.
Rationale - Additionally to thymectomy, which indication of is still debated in absence of
thymoma, the long-term treatment of generalized myasthenia gravis includes usually prednisone
and azathioprine. However, the most used scheme for prescribing and tapering corticosteroid
in MG resulted in a very important cumulative dose of prednisone. Indeed, at twelve month,
more than 50 percent of patients are still daily treated with at least 18 mg of prednisone
and the proportion of patients who are in remission and no longer taking prednisone is very
low (Palace and NEWSOM Davis, Neurology 1998). Prolonged corticosteroid therapy is
accompanied with various and major side effects, hypertension, osteoporosis, weight gain,
glaucoma. Therefore, tapering, eventually discontinuing, prednisone earlier is a relevant
therapeutic goal.
For this reason, the investigators will compare to the standard one, a strategy consisting of
a rapid decrease in corticosteroid.
Objective - To assess whether, in patients with generalized MG requiring a long-term
treatment with corticosteroids and azathioprine, that the strategy of rapid tapering allows
discontinuing more rapidly the prednisone for equivalent efficacy than the classical
strategy.
Status | Completed |
Enrollment | 118 |
Est. completion date | September 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Written consent of the patient, after informing - Generalized MG of grade III, IV or V - Classification MGFA - Follow-up on 15 months possible and accepted by patients Exclusion Criteria: - Age<18 or >80 years - Pregnancy - Myasthenia of grade I or II of MGFA - Patients already treated with prednisone or azathioprine - Contraindication for prednisone or azathioprine - Other associated disease requiring a treatment with prednisone or azathioprine - Weight >100kg - Invasive thymoma |
Country | Name | City | State |
---|---|---|---|
France | Hopital Raymond Poincaré | Garches |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients who have reach minimal manifestation state (according to MGFA criteria) and are not treated with prednisone after 12 months of treatment and have not relapsed during the next 3 months. | 15 months | ||
Secondary | Cumulative dose of prednisone at twelve months | 15 MONTHS | ||
Secondary | Proportion of patients having reached minimal manifestation state 12 months | 15 MONTHS | ||
Secondary | Time for reaching the improvement or minimal manifestation state (MGFA criteria) | 15 MONTHS | ||
Secondary | Frequency of exacerbations within the first 15 months after randomization | 15 MONTHS | ||
Secondary | Frequency of treatment by IvIg or plasma exchange within the first 15 months after randomization | 15 MONTHS | ||
Secondary | Frequency and type of complications related to prednisone. | 15 MONTHS | ||
Secondary | Frequency and type of complications of azathioprine | 15 MONTHS |
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