NL-OMON30649
Completed
Phase 3
A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone - TxMG trial
ational Institute of Health0 sites5 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- myasthenia
- Sponsor
- ational Institute of Health
- Enrollment
- 5
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female MG patients aged 18 to 60 years inclusive (thymectomy is not regularly performed in non\-thymomatous MG patients \> 60 years of age).
- •Onset of generalized MG within the last 3 years.
- •Positive serum anti\-acetylcholine receptor binding antibodies (AChR Ab \<\=/\> 1\.0 nmol/L).
- •MGFA class II\-IV at entry, using the MG Foundation of America (MGFA) classification, while receiving optimal anti\-cholinesterase treatment with or without oral prednisone.
Exclusion Criteria
- •Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would not require the use of corticosteroids.
- •Myasthenic weakness requiring intubation (MGFA class V) in the prior month.
- •Immunosuppressive therapy other than corticosteroids in the preceding year.
- •Medically unfit for thymectomy.
- •Chest computertomogreaphy evidence for thymoma.
- •Pregnancy or lactation; contraindications to the use of corticosteroids; unwillingness to practice effective contraception.
- •A serious concurrent medical, neurological or psychiatric condition.
- •Current daily dose of prednisone of more than 50 mg.
- •Participation in another experimental clinical trial.
- •History of alcohol or drug abuse.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Phase 3
K-103-PA Phase 3 studyJPRN-jRCT2080221217Kowa Co., Ltd.340
Active, not recruiting
Not Applicable
Clinical trial to compare safety and efficacy of CGBIO stent and Biomatrix Flex stent in patients receiving drug-eluting stent after coronary angiographyKCT0003759CGBio118
Active, not recruiting
Phase 1
An examination of which type of medicine (rocuronium or remifentanil) is better concerning placement of a tube in trachea in elderly patients under going anesthesiaThe aim of this study is to determine the effect on intubating conditionsand laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age = 80 years.MedDRA version: 21.1Level: LLTClassification code 10002323Term: Anesthesia generalSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]EUCTR2019-004121-25-DKRigshospitalet74
Active, not recruiting
Phase 1
A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial SpondyloarthritisEUCTR2012-000646-35-BEAbbVie Deutschland GmbH & Co. KG740
Completed
Phase 4
A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial SpondyloarthritisAxial spine arthritisinflammation of the spine and joints1000381610023213NL-OMON41245AbbVie B.V.54