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Trial record 63 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

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

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ClinicalTrials.gov Identifier: NCT02644499
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Vir Singh Negi, Jawaharlal Institute of Postgraduate Medical Education & Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Methotrexate Drug: Leflunomide Drug: Hydroxychloroquine Drug: Prednisolone Drug: Folic Acid Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis
Actual Primary Completion Date : November 17, 2016
Actual Study Completion Date : February 27, 2017

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Arm Intervention/treatment
Active Comparator: Combination therapy
Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. 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) will be given as bridging therapy.
Drug: Methotrexate
Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic dise
Other Name: Folitrax, MTX

Drug: Leflunomide
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 Name: Arava, Lefno

Drug: Hydroxychloroquine
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 Name: HCQ

Drug: Prednisolone
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 Name: Steroids, Glucocorticoids

Drug: Folic Acid
Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Other Name: Folvite, Folate

Active Comparator: Monotherapy
Methotrexate (up to 25 mg once a week) for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. 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) will be given as bridging therapy.
Drug: Methotrexate
Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic dise
Other Name: Folitrax, MTX

Drug: Prednisolone
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 Name: Steroids, Glucocorticoids

Drug: Folic Acid
Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Other Name: Folvite, Folate




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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

Exclusion Criteria:

  1. Disease in Remission/inactive disease (DAS28 criteria)
  2. End stage disease (deformed fixed joints)
  3. Patients with vasculitis or other severe extra-articular features
  4. 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 )
  5. Pregnant, lactating females or inadequate contraception
  6. Patients unable to come for regular follow up

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): NCT02644499


Locations
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India
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
Pondicherry, Pondicherry UT, India, 605006
Sponsors and Collaborators
Jawaharlal Institute of Postgraduate Medical Education & Research
Investigators
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Principal Investigator: Vir S Negi, DM Jawaharlal Institute of Postgraduate Medical Education & Research
Study Chair: Jignesh B Usdadiya, MD Jawaharlal Institute of Postgraduate Medical Education & Research

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Responsible Party: Dr. Vir Singh Negi, Professor and head of the department, Department of Clinical Immunology, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier: NCT02644499     History of Changes
Other Study ID Numbers: JIP/IEC/SC/2013/5/433
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Connective Tissue Diseases
Prednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone Acetate
Methylprednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Hydroxychloroquine
Leflunomide
Antirheumatic Agents
Glucocorticoids
Folic Acid
Vitamin B Complex
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents