Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
NCT ID: NCT01793259
Last Updated: 2013-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2012-07-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
methotrexate prefilled pen
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
methotrexate prefilled pen
methotrexate prefilled syringe
Interventions
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methotrexate prefilled pen
methotrexate prefilled syringe
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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medac GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Ulf Müller-Ladner, MD
Role: PRINCIPAL_INVESTIGATOR
Kerckoff clinic, Bad Nauheim, Germany
Locations
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Kerckhoff Clinic
Bad Nauheim, , Germany
Countries
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References
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Demary W, Schwenke H, Rockwitz K, Kastner P, Liebhaber A, Schoo U, Hubner G, Pichlmeier U, Guimbal-Schmolck C, Muller-Ladner U. Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience. Patient Prefer Adherence. 2014 Aug 6;8:1061-71. doi: 10.2147/PPA.S64111. eCollection 2014.
Other Identifiers
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MC-MTX.11/RA
Identifier Type: -
Identifier Source: org_study_id
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