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Efficacy of Starting Methotrexate Early in Chikungunya Arthritis

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ClinicalTrials.gov Identifier: NCT03058471
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Shefali khanna sharma, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Early Chikungunya Arthritis Drug: Methotrexate Drug: NSAID Drug: Steroids Not Applicable

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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

    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.

At baseline, a complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-Reactive protein(CRP), liver function tests(LFT), Renal Function Test(RFT), rheumatoid factor (RF), anti- citrullinated peptide antibodies (ACPA) will be done. All eligible patients will be randomized to two groups. Randomization will be done by computer generated block randomization in blocks of four and six. In one group methotrexate will be started at a dose of 10 mg/week after checking basal CBC,LFT and RFT and will be increased gradually(5mg/each visit)to 25 mg if there is no response at subsequent visits and the other group will be continued on NSAID.If remission (no swollen or tender joints at the visit) is not achieved in the NSAID group at 2 months they will be given MTX .MTX group will be given NSAID on need basis and this will be recorded in each visit. Both groups will be given depot methyl prednisolone 80 mg ,2 doses 1 week apart if there is 5 or more swollen or tender joints at any visit.The patients will be assessed at 0,1, 2,4 and 6 months for Tender Joint Count(TJC),Swollen joint count( SJC) and Indian Health Assessment Questionnaire(HAQ). If a patient achieves remission in methotrexate group, the last dose of methotrexate will be continued till next visit. The dose will be halved in the next visit and stopped in the next.In the NSAID group, if remission is achieved, dose will be changed to on need basis and if the patient relapses will be started on methotrexate. Allocation concealment will be ensured by means of enclosing the randomization sequence in sealed opaque envelopes. One of the investigator, blinded for the treatment received by the subjects, will assess the subjects at recruitment to the study and subsequently during their next visits and at the end of study period.

Primary efficacy end point will be proportion of patients achieving remission (No tender or swollen joint)at 6 months. Secondary end points will be the time duration to achieve remission, change in DAS28 ESR/CRP score, proportion of patients achieving remission by simplified disease activity index(SDAI) and clinical disease activity index( CDAI) score, functional status assessed by Health Assessment Questionnaire-Indian version (HAQ) , change in pain VAS(Visual Analogue Scale) 100mm,adverse effects and the difference in NSAID and intra muscular steroid injection requirement among the groups.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Starting Methotrexate Early in Chikungunya Arthritis:A 24 Week Randomized Controlled Open Label Crossover Trial
Actual Study Start Date : December 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: methotrexate
mehotrexate 10 mg weekly, to be increased by 5 mg in each visit to a maximum of 25 mg
Drug: Methotrexate
methotrexate arm will be given methotrexate starting at 10 mg weekly to be increased to 25 mg maximum in subsequent visits gradually

Drug: Steroids
inj. depot methyl prednisolone 80 mg ,2 doses deep intramuscularly given one week apart to all patients who have 5 or more swollen or tender joints

Active Comparator: 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
Drug: NSAID
this arm will be given NSAID to the tolerable full dose with pantoprazole

Drug: Steroids
inj. depot methyl prednisolone 80 mg ,2 doses deep intramuscularly given one week apart to all patients who have 5 or more swollen or tender joints




Primary Outcome Measures :
  1. remission [ Time Frame: 6 months ]
    no swollen or tender joints


Secondary Outcome Measures :
  1. change in DAS 28 ESR/CRP [ Time Frame: at 6 months ]
  2. change in functional status assessed by Health Assessment Questionnaire-Indian version (HAQ) [ Time Frame: at 6 months ]
  3. time to remission [ Time Frame: at 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of confirmed CHIK-V infection as per WHO guidelines defined as atleast one of the following

    1. Presence of viral ribonucleic acid in sera determined with 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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058471


Locations
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India
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

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Responsible Party: Shefali khanna sharma, Assosciate professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03058471     History of Changes
Other Study ID Numbers: NK/3088/STUDY
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all study data can be available after the study completion. Contact the auther.
Additional relevant MeSH terms:
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Chikungunya Fever
Arthritis
Joint Diseases
Musculoskeletal Diseases
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors