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Completed

NCT Number: NCT02644499

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

This study will be conducted to find out how well a patient of rheumatoid arthritis (RA) will respond to disease-modifying antirheumatic drugs (DMARDs). RA is a chronic inflammatory arthritis, which leads to joint damage & disability if not treated properly. A DMARD is used to treat RA that slows down or prevents joint damage, as opposed to just relieve pain or inflammation by painkillers. The study will be conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education & Research). Patients will receive either a single DMARD (Methotrexate) or combination DMARDs therapy (Methotrexate + Leflunomide + Hydroxychloroquine). During treatment course, routine blood investigations will be carried out to monitor treatment response and side effects.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)

Puducherry, Pondicherry UT, 605006, India

About this study

Patients aged ≥18 years, fulfilling the 2010 ACR EULAR criteria for RA (symptom duration less than one year) & having moderate to severe disease activity (DAS28≥3.2) will be invited to participate. After providing written informed consent, eligible patients will be stratified into two groups. Block randomization will be done to generate random allocation sequence.

Treatment Group I will be treated with Methotrexate (MTX) monotherapy and Treatment Group II will be treated with Methotrexate + Leflunomide (LEF) + Hydroxychloroquine (HCQ) combination therapy. Concurrent treatment with non-steroidal anti-inflammatory drugs in adequate dose and oral low dose Glucocorticoids (GC) (max: 15 mg/d) will be allowed during the study.

DMARD dosages used are: MTX 25 mg/week orally (dosage after 6 weeks), LEF 20 mg/day (dosage after 2 weeks) and HCQ 400 mg/day. GCs will be given in an oral tapering scheme. All patients will be prescribed folic acid (10 mg/week) during MTX prescription.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years satisfying 2010 ACR (American college of rheumatology) - EULAR criteria for RA
  • Arthritis in one or more joint (s)
  • Symptom duration <1 year
  • DMARD naive
  • Patients with moderate to severe disease activity (DAS28 ≥3.2)

Exclusion criteria

  • Disease in Remission/inactive disease (DAS28 criteria)
  • End stage disease (deformed fixed joints)
  • Patients with vasculitis or other severe extra-articular features
  • Contraindications to DMARD therapy (Chronic Alcoholism, Chronic liver disease, Evidence of acute/chronic infection, Chronic kidney disease, Patients with leucopenia (<3.0×109/l), thrombocytopenia (<150×109/l), aspartate aminotransferase (AST)/alanine aminotransferase (ALT)>2× upper normal value and creatinine level >150 μmol/l )
  • Pregnant, lactating females or inadequate contraception
  • Patients unable to come for regular follow up

Treatment and study plan

methotrexate

Drug

Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic dise

Other names: Folitrax, MTX

leflunomide

Drug

Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease

Other names: Arava, Lefno

Hydroxychloroquine

Drug

Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.

Other names: HCQ

Prednisolone

Drug

Low dose prednisolone (weeks 1-2: 15 mg/day, weeks 2-4: 10 mg/day, weeks 4-6: 5 mg/day and weeks 6-8: 2.5 mg/day then stop)

Other names: Steroids, Glucocorticoids

Folic Acid

Drug

Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.

Other names: Folvite, Folate

Primary outcomes

  1. A good response according to European league against rheumatism (EULAR) response criteria and Functional ability with Indian health assessment questionnaire (iHAQ)

    Time frame: 3 months

    A good response is defined as a decrease after randomization of disease activity score- 28 joints (DAS28) score by >1.2, and a resulting DAS28 score ≤ 3.2.

    Indian version of HAQ (iHAQ) has been validated in patients with RA, which comprises 12 questions (nine basic and three advanced activity of daily living) relevant to the Indian population. For each question there is a four-level difficulty scale ranging from 0 to 3 that represent no difficulty ('0'), some difficulty ('1'), much difficulty ('2'), and inability to do ('3'). The final score is the mean of the highest scores across the eight categories and ranges from 0 to 3, with higher levels indicating more disability.

Secondary outcomes

  1. Mean changes over time in early morning stiffness (EMS)

    Time frame: 3 months

  2. Mean changes over time in erythrocyte sedimentation rate (ESR)

    Time frame: 3 months

  3. Disease activity as per ultrasound (US-7) score

    Time frame: 3 months

  4. Radiographic progression assessed with Simple Erosion Narrowing Score (SENS)

    Time frame: 3 months

  5. Adverse drug reactions

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research

Other Gov

Registry information

Official study title

Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 31, 2015
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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