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A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

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ClinicalTrials.gov Identifier: NCT00396747
Recruitment Status : Completed
First Posted : November 7, 2006
Last Update Posted : October 19, 2007
Sponsor:
Information provided by:
Université Catholique de Louvain

Brief Summary:
The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate Drug: Methotrexate + Methylprednisolone Drug: Methotrexate + Infliximab Phase 4

Detailed Description:
The effects of Glucocorticoïds and Infliximab have never been compared in early RA using MRI as primary outcome measure. In the current study, we compare the effects of MTX alone or in combination with intravenous (IV) methylprednisolone (MP) pulse therapy or IFX on MRI-detected synovitis, bone edema and erosive changes in early RA patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone
Study Start Date : June 2003
Actual Study Completion Date : September 2005


Arm Intervention/treatment
Active Comparator: A
Methotrexate
Drug: Infliximab, methylprednisolone, methotrexate
Drug: Methotrexate
Active Comparator: B
MTX + MP
Drug: Infliximab, methylprednisolone, methotrexate
Drug: Methotrexate + Methylprednisolone
Active Comparator: C
MTX + IFX
Drug: Infliximab, methylprednisolone, methotrexate
Drug: Methotrexate + Infliximab



Primary Outcome Measures :
  1. MRI synovitis, bone edema and erosions score [ Time Frame: baseline, week 18 and 52 ]

Secondary Outcome Measures :
  1. Efficacy (DAS Score, ACR response) [ Time Frame: every 2 months ]
  2. Side effects [ Time Frame: every visit ]


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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:

  • Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count [SJC] ≥ 6 [by the 66 joints count] and a tender joint count [TJC] ≥ 8 [by the 68 joints count]) and had not been treated with MTX before.
  • Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count [SJC] ≥ 6 [by the 66 joints count] and a tender joint count [TJC] ≥ 8 [by the 68 joints count]) and had not been treated with MTX before.

Exclusion Criteria:

  • Exclusion criteria included past/current history of tuberculosis, congestive heart disease, past treatment with GC for more than 3 months (and not during the 4 weeks before inclusion), previous treatment with more than 2 DMARDs, MTX, IV MP pulse.

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): NCT00396747


Locations
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Belgium
Université catholique de Louvain
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
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Principal Investigator: Patrick Durez, MD Université Catholique de Louvain

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00396747     History of Changes
Other Study ID Numbers: CIERA
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: October 19, 2007
Last Verified: October 2007
Keywords provided by Université Catholique de Louvain:
Early rheumatoid arthritis,
glucocorticoids,
pulse therapy,
infliximab,
TNF blockade
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methotrexate
Infliximab
Prednisolone hemisuccinate
Prednisolone phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors