| CTRI Number |
CTRI/2024/02/062433 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
RitUximab in Guillain-Barré sYndrome (RUGBY) trial |
|
Scientific Title of Study
|
RitUximab in Guillain-Barré sYndrome (RUGBY) trial: a single center, double-blind, randomized phase 3 trial |
| Trial Acronym |
RUGBY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayush Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room 705,
Cardioneurosciences Centre,
AIIMS, New Delhi
N/A
South West
DELHI
110029
India |
| Phone |
8193900444 |
| Fax |
- |
| Email |
ayushthetaurian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayush Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room 705,
Cardioneurosciences Centre,
AIIMS, New Delhi
N/A
South West
DELHI
110029
India |
| Phone |
8193900444 |
| Fax |
- |
| Email |
ayushthetaurian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayush Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room 705,
Cardioneurosciences Centre,
AIIMS, New Delhi
N/A
South West
DELHI
110029
India |
| Phone |
8193900444 |
| Fax |
- |
| Email |
ayushthetaurian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Science & Engineering Research Board (SERB) |
|
|
Primary Sponsor
|
| Name |
Science & Engineering Research Board (SERB) |
| Address |
3rd & 4th Floor, Block II,
Technology Bhawan,
New Mehrauli Road
New Delhi - 110 016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayush Agarwal |
AIIMS New Delhi |
Department of Neurology,
AIIMS, New Delhi
South West
DELHI |
8193900444
ayushthetaurian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Rituximab |
Rituximab (1000mg) will be administered at presentation and at 2 weeks to GBS patients who have been considered for or already receiving IVIg treatment. The first dose of Rituximab will be given before the last IVIg dose. The infusion of Rituximab will be in hospital and under direct observation of the medical staff. Administration will be stopped in case of occurrence of severe infusion reactions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Fulfilling the Brighton Collaboration
Diagnostic Criteria for GBS [11]:
a. Bilateral and flaccid paralysis of limbs AND
b. Decreased or absent tendon reflexes in weak
limbs AND
c. Monophasic illness pattern and interval between onset and nadir of weakness between 12 hours and 28 days with subsequent clinical plateau AND
d. Absence of an identified alternative
diagnosis for weakness
2.Presentation within 2 weeks on symptom onset
3.Patient unable to walk unassisted for ≥ 5
metres (Hughes score 3-5)
4.Undergoing treatment with IVIg
5.First dose of Rituximab administered within
2 weeks of symptom onset
6.Signed informed consent for participation in
the study
|
|
| ExclusionCriteria |
| Details |
1.Pregnant/ lactating women
2.GBS patients treated with plasma exchange
3.Patients who have received other immunosuppressants (Azathioprine, Mycophenolate, Methotrexate) within 4 weeks or Rituximab within 24 weeks prior to informed consent
4.Severe comorbid diseases like chronic liver disease, chronic kidney disease, malignancy, tuberculosis or chronic obstructive pulmonary disease
5.Presence of an active, inadequately treated, infection
6.Known immunocompromised state (hereditary or acquired)
7.Participation in any other clinical trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients who are able to ambulate independently (Hughes score≤ 2) at 4- and 24-weeks post symptom onset. |
4 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with improvement of Hughes score by ≥1 at each visit, duration required for improvement in Hughes score by 1, occurrence of relapse, overall survival and improvement in nerve conduction studies at 24 weeks. |
Each follow up visit |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/01/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Guillain Barre syndrome (GBS) is an immune mediated polyradiculoneuropathy that causes acute flaccid paralysis. Intravenous immunoglobulin (IVIg) and plasmapheresis (PLEX) are equally effective in treatment and form the standard of care. However, approximately 25% patients have residual disability despite treatment, and require support for ambulation/ ventilation. Recent studies have shown that B cell and complement activation play a central role in GBS-associated neuronal degeneration. Eculizumab is a monoclonal antibody which inhibits C5 complement, and has proven beneficial in two randomized controlled trials on GBS (ICA-GBS and JET-GBS). Rituximab is a chimeric monoclonal antibody which binds to CD20 antigens on B cells inducing their cytolysis, thereby decreasing downstream B-cell and complement mediated axonal damage. Since its mechanism of action includes that of Eculizumab, it is likely to be as effective and the cost of Rituximab in India is 1/50th that of Eculizumab. |