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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

  Show Detailed Description

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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
Antimetabolites, Antineoplastic
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
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors