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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

MedlinePlus related topics: Edema MRI Scans Rheumatoid Arthritis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Methotrexate Medrol veriderm Methylprednisolone Infliximab Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

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
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

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

No publications provided by Université Catholique de Louvain

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

Keywords provided by Université Catholique de Louvain:

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

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone

Prednisolone phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012