Multiple Sclerosis MedDRA version: 12.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Product Name: Teriflunomide
Product Code: HMR 1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: Teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligr
Sponsors
Sanofi-Aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Multiple Sclerosis patients who have completed the last study visit (visit 14) at week 24 of either study PDY6045 or PDY6046, and who are still meeting eligibility criteria for receiving treatment in the previous study and with a signed informed consent to extend their participation. An informed consent must be obtained in writing from the subject for this extension study prior to enrollment. Subjects must be willing to continue their current interferon or glatiramer acetate therapy and continue their double-blinded treatement. For those subjects that have not had HIV testing in the core studies (PDY6045 or PDY6046) an informed consent must be signed for LTS6047. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia • Hematocrit 1.5-fold the upper limit of normal (ULN) 11. Persisting elevations of serum amylase or lipase greater than 2-fold the upper limit of normal 12. Known history of chronic active hepatitis 13. Known history of chronic pancreatic disease or pancreatitis 14. Hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin 133 µmol/L (or >1.5 mg/dL) 16. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol 17. Clinically relevant cardiovascular, hypertensive (defined as blood pressure [BP] =160/100 mm/Hg), hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participating in the study 18. Severe depressive disorder and/or suicidality 19. Unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study 20. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document the long-term safety and tolerability of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses;Secondary Objective: To document the long-term effect on relapse rate, disability rate and MRI variables;Primary end point(s): Safety ( Adverse event reports,laboratory parameters,ECG,CT of MRI image of pancreas and vitals signs) | — |
Countries
Austria, Italy, Spain, United Kingdom
Outcome results
None listed