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

NCT01793259 | Completed Phase 3

• 1 other identifier: MC-MTX.11/RA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• number of patients preferring the MTX pre-filled pen to the pre-filled syringe

  after 6 weeks of treatment

Study Arms (2)

prefilled pen then prefilled syringe

OTHER

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

OTHER

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

Interventions

methotrexate prefilled pen DRUG

prefilled pen then prefilled syringe; prefilled syringe then prefilled pen

methotrexate prefilled syringe DRUG

prefilled pen then prefilled syringe; prefilled syringe then prefilled pen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• medac GmbH: lead

Study Sites (1)

Kerckhoff Clinic

Bad Nauheim, 61231, Germany

Location

Related Publications (1)

• 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.

  PMID: 25125973 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ulf Müller-Ladner, MD

  Kerckoff clinic, Bad Nauheim, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

DE (1)