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

Sponsored by:	Université Catholique de Louvain
Information provided by:	Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00396747

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate Drug: Methotrexate + Methylprednisolone Drug: Methotrexate + Infliximab	Phase IV

MedlinePlus related topics: Edema MRI Scans Rheumatoid Arthritis

Drug Information available for: Methotrexate Methylprednisolone Infliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:

MRI synovitis, bone edema and erosions score [ Time Frame: baseline, week 18 and 52 ]

Secondary Outcome Measures:

Efficacy (DAS Score, ACR response) [ Time Frame: every 2 months ]
Side effects [ Time Frame: every visit ]

Enrollment:	45
Study Start Date:	June 2003
Study Completion Date:	September 2005

Arms	Assigned Interventions
A: Active Comparator Methotrexate	Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate
B: Active Comparator MTX + MP	Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate + Methylprednisolone
C: Active Comparator MTX + IFX	Drug: Infliximab, methylprednisolone, methotrexate Drug: Methotrexate + Infliximab

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396747

Locations

Belgium
Université catholique de Louvain
Brussels, Belgium, 1200

Sponsors and Collaborators

Université Catholique de Louvain

Investigators

Principal Investigator:

Patrick Durez, MD

Université Catholique de Louvain

More Information

Publications indexed to this study:

Durez P, Malghem J, Nzeusseu Toukap A, Depresseux G, Lauwerys BR, Westhovens R, Luyten FP, Corluy L, Houssiau FA, Verschueren P. Treatment of early rheumatoid arthritis: a randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone. Arthritis Rheum. 2007 Dec;56(12):3919-27.

Study ID Numbers:	CIERA
Study First Received:	November 6, 2006
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00396747
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Université Catholique de Louvain:

Early rheumatoid arthritis,
glucocorticoids,
pulse therapy,
infliximab,
TNF blockade

Study placed in the following topic categories:

Autoimmune Diseases
Infliximab
Methylprednisolone
Joint Diseases
Arthritis, Rheumatoid
Methylprednisolone acetate
Prednisolone acetate
Rheumatic Diseases

Folic Acid
Musculoskeletal Diseases
Arthritis
Prednisolone
Connective Tissue Diseases
Methotrexate
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Hormones
Neuroprotective Agents
Therapeutic Uses
Abortifacient Agents
Dermatologic Agents

Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009