Prospective, multicentre, open label, clinical study to evaluate efficacy and safety of R-TPR-011 in patients with multiple sclerosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 11
- 主要终点
- To assess the number of new gadolinium enhancing lesions by serial MRI of the brain during the treatment period.
研究概览
简要总结
This study was a prospective, open-label, multicentric single arm trial. Subjects with the diagnosis of relapsing remitting multiple sclerosis fulfilling McDonald criteria and meeting all eligibility criteria were enrolled in the study. Subjects were followed at week 4, week 8, week 12, week 16, week 20, week 26 and further will be followed up to week 52. Vitals, clinical exacerbations, ambulation index, disability scores, hemogram, biochemistry, thyroid hormones and MRI Scan were observed/ performed as per the study schedule at predefined intervals. The primary objective was to assess new gadolinium enhancing lesions in brain over 26 weeks of treatment period in patients of relapsing remitting multiple sclerosis. Each subject received a dose of 30 ìg of R-TPR-011 intra muscularly once a week for 26 weeks and additionally, treatment was given once a week for another 26 weeks for secondary efficacy analysis. Patients at each site were enrolled only after receiving approval from the respective Ethics committee. All patients were required to give written informed consent prior to enrolment in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of relapsing remitting multiple sclerosis based upon McDonald criteria at the time of entry Subject having atleast 2 exacerbations in the 2 years prior to but stable for atleast 4 weeks before study entry Subject with EDSS ≤5.0 Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures/documented to be postmenopausal 1.Able to comprehend and give informed consent for the study and willing to come for follow up visit as per protocol requirement 2.Consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent.
- •However, when the subject is stable and is able to give consent, consent would be obtained on a separate ICF to confirm his/her willingness to continue in the study.
排除标准
- •1.Diagnosis of primary and/or secondary progressive MS.
- •â€¢(Primary progressive MS: Patients that develop a sustained deterioration of their neurological function from the beginning, •Secondary progressive MS: Patients with relapsing remitting MS eventually develop sustained deterioration with or without relapses superimposed).
- •2.Patients with h/o and/or current severe depression and/or suicidal ideation.
- •3.Patients on steroids for treatment of MS within preceding 4 weeks.
- •4.History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; and/or other medical conditions that would preclude therapy with interferon beta.
- •5.Patients with Serum creatinine 1.5 x ULN.
- •6.History of severe allergic and/or anaphylactic reactions and/or history of hypersensitivity to human albumin 7.History of seizures within the 3 months prior to starting this study.
- •8.History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs that would preclude use of atleast one of these during the study.
- •9.History of intolerance and/or hypersensitivity to interferons and/or to any of the excipients.
- •12.Subject participation in another clinical trial 30 days prior to administration of IP.
- •13.Pregnant and lactating females.
- •14.Any other condition which investigator feels would pose a significant hazard to subject if IP is administered.
结局指标
主要结局
To assess the number of new gadolinium enhancing lesions by serial MRI of the brain during the treatment period.
时间窗: 26 weeks of treatment period
次要结局
- Evaluation of safety(Evaluation of safety will be based on)