Health Condition 1: null- Rheumatoid arthritis
Conditions
Interventions
Intervention1: Methotrexate: This is an observational study so pts who are on existent long term treatment with methotrexate either oral or parenteral were recruited.
Intervention2: not applicable: s
Sponsors
institutional Dept of Pharmacology IPGMER
Eligibility
Inclusion criteria
Inclusion criteria: 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 = 2 years duration. 3.Patients on parenteral methotrexate therapy at a dose of = 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OBJECTIVES 1.To estimate the frequency of hepatic adverse effects of long term low dose methotrexate therapy in rheumatoid arthritis patients. 2.To estimate the frequency of haematological adverse effects of long term low dose methotrexate therapy in rheumatoid arthritis patients. Timepoint: only on recruitment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY OBJECTIVES 1.To characterize the pattern of hepatic toxicity in terms of extent of rise of liver enzymes. 2.To identify potential risk factors for hepatic and hematological adverse effects.Timepoint: cross sectional so evaluated only at recruitment visit | — |
Countries
India
Contacts
Public ContactLily Dubey
IPGMER
Outcome results
None listed