Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871961
• Other study ID #: MC-MTX.15/HF
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2013
• Last updated: March 13, 2015
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2015
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis

• Male or female patient who is 16 years of age or older

Exclusion Criteria:

• Is a female patient who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control during the study and at least 6 months thereafter

• Has any history of hypersensitivity to the investigational medicinal product

• Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than Rheumatoid Arthritis (RA)

• Is unable to comprehend written labeling and training materials

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• Methotrexate (Metoject® prefilled pen)

Locations

Country	Name	City	State
United States	Rheumatology Arthitis & Rheumatic Care center	South Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
medac GmbH	PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).	Questionnaires to assess the comprehension of the label (instruction for use of the prefilled pen) and device robustness evaluation after usage of the prefilled pen	1 year	Yes