| CTRI Number |
CTRI/2009/091/000655 [Registered on: 20/08/2009] |
| Last Modified On: |
05/11/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Biological |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to study the effect of R-TPR-011 in patients with multiple sclerosis |
Scientific Title of Study
Modification(s)
|
Prospective, multicentre, open label, clinical study to evaluate efficacy and safety of R-TPR-011 in patients with multiple sclerosis. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| RLS/TP/2009/01, version 2.0 dated 7th March 2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Parvez Kosgi |
| Designation |
Head RLS Clinical Trials |
| Affiliation |
Reliance Life Science Pvt. Ltd. |
| Address |
Dhirubhai Ambani Life Sciences Centre
Plot No. R 282 TTC Area of MIDC
Thane Belapur Road Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02240678000 |
| Fax |
02240678299 |
| Email |
parvez.kosgi@relbio.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Devi Manjula |
| Designation |
Medical Monitor |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
CPR TOWERS, # 65-373-2, 100 ft.
Ring Road,BTM Layout 2nd Stage,
Bangalore
Mumbai
MAHARASHTRA
400701
India |
| Phone |
02267678000 |
| Fax |
02267678299 |
| Email |
devi.manjula@relbio.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Parvez Kosgi |
| Designation |
Head RLS clinical Trial |
| Affiliation |
Reliance Life Sciences Pvt. Ltd |
| Address |
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02267678000 |
| Fax |
02267678299 |
| Email |
parvez.kosgi@relbio.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Reliance Life sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India |
|
Primary Sponsor
Modification(s)
|
| Name |
Reliance Life Sciences Pvt Ltd |
| Address |
Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand Kumar |
Amrita Institute of Medical Sciences and Research Centre |
Amrita Lane, Elamakkara Post,-682026
Ernakulam
KERALA |
04842801234
anandkumar@aims.amrita.edu |
| Dr Sudhir Kumar |
Apollo Hospitals |
Jubilee Hills, Hyderabad-560033
Rangareddi
ANDHRA PRADESH |
9866193953
drsudhirkumar@yahoo.com |
| Dr A B Shah |
BYL Nair Hospital |
Dr. AL Nair Road, Mumbai Central,-400008
Mumbai
MAHARASHTRA |
02223620826
drshahbarvn@hotmail.com |
| Dr Suresh Chandran |
Health and Research Center, Medical College |
Health and Research Center, Medical College, Trivendrum 695011
Thiruvananthapuram
KERALA |
04712554911
healthtrials@gmail.com |
| Dr Mukul Varma |
Indraprasth Apollo Hospitals |
Apollo Neurosciences Centre, Mathura Road, Sarita Vihar,-110076
New Delhi
DELHI |
01126925858
mukulvarma@hotmail.com |
| Dr Bashir Ahmadi |
Medisurge Hospital |
Neurophyscians, M 4, Mahakant Building, Ellishbridge,-380006
Ahmadabad
GUJARAT |
07926578096
bashir@myclinic.co.in |
| Dr Neetu Ramrakhiani |
S. K. Soni Hospital |
Department of Neurology, S K Soni Hospital,-302015
Jaipur
RAJASTHAN |
9314932648
neetudilip@yahoo.co.in |
| Dr Hemant Sant |
Sahyadri Speciality Hospitals |
Plot No. 30C, Deccan Gymkhana,-411005
Pune
MAHARASHTRA |
02025882415
cru@sahayadrihospitals.com |
| Dr Sangeeta Rawal |
Seth GS Medical College and KEM Hospital |
Seth GS Medical College and KEM Hospital
Acharya Donde Marg, Parel
Mumbai
MAHARASHTRA |
9820310850
ravatsh@yahoo.com |
| Dr Anand Diwan |
Shatabdi Superspeciality Hospital |
Opp. Mahanagar Palika Bus Depot, Mumbai Naka,-422005
Nashik
MAHARASHTRA |
9960005088
dr_andu@rediffmail.com |
| Dr Gosala Kukkuta Sama |
St. Johns Medical College and Hospital |
Department of Neurology, St. Johns Medical College and Hospital, Sarjpur,-560034
Bangalore
KARNATAKA |
08022065330
grk_sama@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee on Clinical Trials, Indraprasth Hospitals, New Delhi. |
Approved |
| Ethics Committee Seth G S Medical College and KEM Hospital, Mumbai |
Approved |
| Ethics Committee Shatabdi Hospital, Nasik |
Approved |
| Ethics Committee VYL Nair Hospital, Mumbai |
Approved |
| Ethics Committee, Apollo Health Hospitals, Hyderabad. |
Approved |
| HCG_Medi Surge Ethics Committee Ahmedabad |
Approved |
| Independent Human Ethics Committee, Trivandrum |
Approved |
| Institutiona Ethics Committee, Amrita Institute of Medical Sciences, Kochi |
Approved |
| Institutional Ethical Review Board, St. Johns Medical College and Hospital |
Approved |
| Sahyadri Speciality Hospital Ethics Committee, Pune |
Approved |
| Searoc, S. K. Soni Hospital, Pvt Ltd. Jaipur. |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with Multiple Sclerosis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
R-TPR-011 (Interferon Beta) |
Dose: 30 microgram, Frequency: once in a week, Route of Administration: Intramuscularly, Duration: 52 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
10. Previous use of interferon beta within 1 week prior to enrolment.
11. Subjects positive for HIV, HBsAg or HCV.
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. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 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
Modification(s)
|
| Outcome |
TimePoints |
| Evaluation of safety |
Evaluation of safety will be based on
• Number of persistent enhancing lesions (enhancing lesions that were present on the previous scan) from baseline to week 26
• Change in lesion volume from baseline to week 26 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
23/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/App |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 |