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Effect of two different combination drug therapies on control of joints inflammation in rheumatoid arthritis

comparing the time to normalize "erythrocyte sedimentation rate" following two combination therapies in rheumatoid arthritis patients: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012110611383N1
Enrollment
52
Registered
2012-11-30
Start date
2005-09-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESR normalization and remission in response to treatment in rheumatoid arthritis. Rheumatoid arthritis, unspecified

Interventions

Intervention 1: Group 1 was treated by Methotrexate, Chloroquine and Prednisolone (MTX group). Chloroquine was prescribed with 150mg daily. Methotrexate was started with 0.2 mg/kg weekly and increas
Treatment - Drugs
Group 1 was treated by Methotrexate, Chloroquine and Prednisolone (MTX group). Chloroquine was prescribed with 150mg daily. Methotrexate was started with 0.2 mg/kg weekly and increased 2.5 mg monthl
Group 2 was treated by Azathioprine, Chloroquine and Prednisolone. Azathioprine and Chloroquine were started with 2 mg/kg/day and 150 mg/day, respectively. Prednisolone was started with 0.3 mg/kg/day

Sponsors

Rheumatology Department, Valiasr Hospital, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: the age of 18 and over; fulfilling the the American College of Rheumatology criteria 1987 for rheumatoid arthritis; active disease which specified by ESR equal to or more than 20 in males and equal to or more than 30 in females; morning stiffness more than 30 minutes and equal to or more than 3 joints involved in physical exam. Exclusion criteria: stage IV disease; previous combination therapy with the same medication as in this study; liver or renal failure; pregnancy; active or chronic infection; anemia; ophthalmic complications of Chloroquine during follow up; patients with irregular visits; the patients without drug compliance and special medical complications such as rise of serum creatinine.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
ESR normalization (time to normalize ESR and percentage of normalization). Timepoint: 2nd, 4th, 6th, 8th, 18th, 34th week. Method of measurement: westergren method.

Secondary

MeasureTime frame
Remission (time and percentage of achieving remission). Timepoint: 2nd, 4th, 6th, 8th, 18th, 34th week. Method of measurement: clinical with physical exam and also ESR.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Sasan Fallahi

Kerman University of Medical Sciences

drsfallahi@gmail.com+98 34 1211 5817

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026