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Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793259
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):
medac GmbH

Brief Summary:
The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a questionnaire

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: methotrexate prefilled pen Drug: methotrexate prefilled syringe Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis
Study Start Date : July 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
prefilled pen then prefilled syringe
weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks
Drug: methotrexate prefilled pen
Drug: methotrexate prefilled syringe
prefilled syringe then prefilled pen
weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks
Drug: methotrexate prefilled pen
Drug: methotrexate prefilled syringe



Primary Outcome Measures :
  1. number of patients preferring the MTX pre-filled pen to the pre-filled syringe [ Time Frame: after 6 weeks of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Age between 18 and 75 years
  • Rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria 1987 or ACR/European Liga Against Rheumatology (EULAR)2010
  • Disease activity score (DAS) 28 > 2.6

Main Exclusion Criteria:

  • Prior or other current subcutaneous treatment with self-injection
  • Prior or concomitant treatment with biologics
  • Contraindications to MTX treatment
  • History or diagnosis of a dermatological disease at the injection site
  • Women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.

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): NCT01793259


Locations
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Germany
Kerckhoff Clinic
Bad Nauheim, Germany, 61231
Sponsors and Collaborators
medac GmbH
Investigators
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Principal Investigator: Ulf Müller-Ladner, MD Kerckoff clinic, Bad Nauheim, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: medac GmbH
ClinicalTrials.gov Identifier: NCT01793259    
Other Study ID Numbers: MC-MTX.11/RA
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013
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
Methotrexate
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
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors