Clinical Trial: Efficacy of Starting Methotrexate Early in Chikungunya Arthritis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional




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

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 Summary:

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

    1. Presence of viral ribonucleic acid in sera determined with Real Time Polymerase Chain Reaction(RT PCR) in acute phase < 7 days of fever
    2. Presence of virus specific IgM antibodies in serum
  2. Persistent arthritis after 4 weeks of onset of fever and duration less than 12 weeks(early post viral arthritis)
  3. Age more than 16 years
  4. Patients willing to give informed consent

Exclusion Criteria:

  1. Patients with mixed infection i.e. dengue.
  2. Having a known rheumatological disease and currently taking treatment
  3. Pregnant and breastfeeding women
  4. Any contraindication to methotrexate(Mtx)

The clinical details of patients will be recorded in the proforma which includes details regarding the fever and musculoskeletal symptoms.

no swollen or tender joints



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • change in DAS 28 ESR/CRP [ Time Frame: at 6 months ]
  • change in functional status assessed by Health Assessment Questionnaire-Indian version (HAQ) [ Time Frame: at 6 months ]
  • time to remission [ Time Frame: at 6 months ]


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research




Dates:
Date Received: February 13, 2017
Date Started: December 2016
Date Completion: May 2018
Last Updated: February 21, 2017
Last Verified: February 2017