A clinical trial to study the effect of R-TPR-011 in patients with multiple sclerosis

Phase 3

Completed

• Conditions: Patients with Multiple Sclerosis

• Registration Number: CTRI/2009/091/000655
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-23
• Last Update Posted: 2014-05-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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.

Exclusion Criteria

• 1.Diagnosis of primary and/or secondary progressive MS.
• •(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the number of new gadolinium enhancing lesions by serial MRI of the brain during the treatment period.	26 weeks of treatment period

Secondary Outcome Measures

Name	Time	Method
Evaluation of safety	Evaluation of safety will be based on

Trial Locations

Locations (11)

Amrita Institute of Medical Sciences and Research Centre; 🇮🇳 Ernakulam, KERALA, India

Apollo Hospitals; 🇮🇳 Rangareddi, ANDHRA PRADESH, India

BYL Nair Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Health and Research Center, Medical College; 🇮🇳 Thiruvananthapuram, KERALA, India

Indraprasth Apollo Hospitals; 🇮🇳 Delhi, DELHI, India

Medisurge Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

S. K. Soni Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Sahyadri Speciality Hospitals; 🇮🇳 Pune, MAHARASHTRA, India

Seth GS Medical College and KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Shatabdi Superspeciality Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

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Amrita Institute of Medical Sciences and Research Centre

🇮🇳Ernakulam, KERALA, India

Dr Anand Kumar

Principal investigator

04842801234

anandkumar@aims.amrita.edu