Safety of Long term Methotrexate use in rheumatoid arthritis
- Conditions
- Health Condition 1: null- Rheumatoid arthritis
- Registration Number
- CTRI/2015/05/005773
- Lead Sponsor
- institutional Dept of Pharmacology IPGMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
1.Adult patients of age >= 18 years of either sex with a clinical diagnosis of rheumatoid arthritis as per American College of Rheumatology (ACR) 2010 guidelines.
2.Patients on oral methotrexate therapy at a dose of <= 15mg weekly for >= 2 years duration.
3.Patients on parenteral methotrexate therapy at a dose of <=15mg weekly for >= 2 years duration.
4.Patients either on monotherapy with methotrexate or on combination therapy of methotrexate with any other DMARD or immunobiological agents.
5.Subjects willing to give written informed consent and comply with study related instructions.
Subjects who are on methotrexate therapy for less than 2 years.
2. Subjects who are on methotrexate oral dose >15mg weekly or parenteral dose >15 mg weekly
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PRIMARY OBJECTIVES <br/ ><br> <br/ ><br>1.To estimate the frequency of hepatic adverse effects of long term low dose methotrexate therapy in rheumatoid arthritis patients. <br/ ><br>2.To estimate the frequency of haematological adverse effects of long term low dose methotrexate therapy in rheumatoid arthritis patients. <br/ ><br> <br/ ><br>Timepoint: only on recruitment visit
- Secondary Outcome Measures
Name Time Method SECONDARY OBJECTIVES <br/ ><br> <br/ ><br>1.To characterize the pattern of hepatic toxicity in terms of extent of rise of liver enzymes. <br/ ><br>2.To identify potential risk factors for hepatic and hematological adverse effects.Timepoint: cross sectional so evaluated only at recruitment visit