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Clinical Trials/NCT03058471
NCT03058471CompletedNot Applicable

Efficacy of Starting Methotrexate Early in Chikungunya Arthritis:A 24 Week Randomized Controlled Open Label Crossover Trial

Post Graduate Institute of Medical Education and Research, Chandigarh1 site in 1 country60 target enrollmentStarted: December 2016Last updated:
Conditions
Interventions
Drugs

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

  1. Patients of confirmed Chikungunya virus infection as per World Health Organisation(WHO) guidelines defined as atleast one of the following

  2. Presence of viral ribonucleic acid in sera determined with Real Time Polymerase Chain Reaction(RT PCR) in acute phase < 7 days of fever

  3. Presence of virus specific IgM antibodies in serum

  4. Persistent arthritis after 4 weeks of onset of fever and duration less than 12 weeks(early post viral arthritis)

  5. Age more than 16 years

  6. 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

Active Comparator

mehotrexate 10 mg weekly, to be increased by 5 mg in each visit to a maximum of 25 mg

Intervention: Methotrexate (Drug)

methotrexate

Active Comparator

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

Active Comparator

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

Active Comparator

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

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shefali khanna sharma

Assosciate professor

Post Graduate Institute of Medical Education and Research, Chandigarh

Study Sites (1)

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