NCT01871961

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

May 14, 2013

Last Update Submit

March 13, 2015

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Methotrexate

EXPERIMENTAL
Drug: Methotrexate (Metoject® prefilled pen)

Interventions

Methotrexate (Metoject® prefilled pen)DRUG
Methotrexate

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
  • Male or female patient who is 16 years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Arthitis & Rheumatic Care center

South Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

June 7, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(1)