Efficacy of Starting Methotrexate Early in Chikungunya Arthritis:A 24 Week Randomized Controlled Open Label Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- remission
Study Overview
Brief Summary
This is a single center, prospective, randomized controlled open label trial with a one sided cross over design to compare the efficacy of initiating Methotrexate(Mtx) in early post Chikungunya induced arthritis (4-12 weeks after onset) with Non Steroidal Anti inflammatory Drugs(NSAID) alone.
Detailed Description
This will be a single center, prospective, randomized controlled open label trial with a cross over design. Patients will be recruited from outpatient department of internal medicine and rheumatology clinic of Post Graduate Institute of Medical Education and Research(PGIMER), Chandigarh, India, a tertiary care hospital. .
Inclusion Criteria
-
Patients of confirmed Chikungunya virus infection as per World Health Organisation(WHO) guidelines defined as atleast one of the following
-
Presence of viral ribonucleic acid in sera determined with Real Time Polymerase Chain Reaction(RT PCR) in acute phase < 7 days of fever
-
Presence of virus specific IgM antibodies in serum
-
Persistent arthritis after 4 weeks of onset of fever and duration less than 12 weeks(early post viral arthritis)
-
Age more than 16 years
-
Patients willing to give informed consent
Exclusion Criteria:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of confirmed CHIK-V infection as per WHO guidelines defined as atleast one of the following
- •Presence of viral ribonucleic acid in sera determined with RT -PCR in acute phase < 7 days of fever
- •Presence of virus specific IgM antibodies in serum
- •Persistent arthritis after 4 weeks of onset of fever and duration less than 12 weeks
- •Age more than 16 years
- •Patients willing to give informed consent
Exclusion Criteria
- •Patients with mixed infection i.e. dengue.
- •Having a known rheumatological disease and currently taking treatment
- •Pregnant and breastfeeding women
- •Any contraindication to methotrexate
Arms & Interventions
methotrexate
mehotrexate 10 mg weekly, to be increased by 5 mg in each visit to a maximum of 25 mg
Intervention: Methotrexate (Drug)
methotrexate
mehotrexate 10 mg weekly, to be increased by 5 mg in each visit to a maximum of 25 mg
Intervention: Steroids (Drug)
non steroidal anti inflammatory drugs
NSAID in full dose with Pantoprazole. If remission not achieved at 2 months, will be given methotrexate as in methotrexate arm
Intervention: NSAID (Drug)
non steroidal anti inflammatory drugs
NSAID in full dose with Pantoprazole. If remission not achieved at 2 months, will be given methotrexate as in methotrexate arm
Intervention: Steroids (Drug)
Outcomes
Primary Outcomes
remission
Time Frame: 6 months
no swollen or tender joints
Secondary Outcomes
- change in DAS 28 ESR/CRP(at 6 months)
- change in functional status assessed by Health Assessment Questionnaire-Indian version (HAQ)(at 6 months)
- time to remission(at 6 months)
Investigators
Shefali khanna sharma
Assosciate professor
Post Graduate Institute of Medical Education and Research, Chandigarh