Health Condition 1: G610- Guillain-Barre syndrome
Conditions
Interventions
Intervention1: 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 o
Sponsors
Science & Engineering Research Board (SERB)
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who are able to ambulate independently (Hughes score= 2) at 4- and 24-weeks post symptom onset.Timepoint: 4 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Each follow up visit | — |
Countries
India
Contacts
Public ContactAyush Agarwal
AIIMS, New Delhi
Outcome results
None listed