Back to resultsPreference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
methotrexate prefilled pen
methotrexate prefilled syringe
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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.
Sites / Locations
- Kerckhoff Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
prefilled pen then prefilled syringe
prefilled syringe then prefilled pen
Arm Description
weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks
weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks
Outcomes
Primary Outcome Measures
number of patients preferring the MTX pre-filled pen to the pre-filled syringe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01793259
Brief Title
Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
medac GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prefilled pen then prefilled syringe
Arm Type
Other
Arm Description
weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks
Arm Title
prefilled syringe then prefilled pen
Arm Type
Other
Arm Description
weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks
Intervention Type
Drug
Intervention Name(s)
methotrexate prefilled pen
Intervention Type
Drug
Intervention Name(s)
methotrexate prefilled syringe
Primary Outcome Measure Information:
Title
number of patients preferring the MTX pre-filled pen to the pre-filled syringe
Time Frame
after 6 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Müller-Ladner, MD
Organizational Affiliation
Kerckoff clinic, Bad Nauheim, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerckhoff Clinic
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25125973
Citation
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.
Results Reference
derived
Learn more about this trial
Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
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