Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept
Status: | Completed |
---|---|
Conditions: | Arthritis, Psoriasis, Rheumatoid Arthritis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/5/2018 |
Start Date: | June 11, 2013 |
End Date: | December 30, 2013 |
A Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject Etanercept
The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA)
or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept
(Enbrel®).
or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept
(Enbrel®).
Study participants need to have been self-administering etanercept for greater than or equal
to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a
4-week screening period and a 5-week treatment period.
to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a
4-week screening period and a 5-week treatment period.
Inclusion Criteria:
- Subject has diagnosis of RA or PsA and indicated for treatment with etanercept per the
current label, based on history.
- Subject is willing to self-inject per investigator judgement at screening.
- Subject has no known history of tuberculosis.
Exclusion Criteria:
- Latex allergy.
- Subject has any active infection (including chronic or localized infections) for which
anti-infectives were indicated within 4 weeks prior to first study dose of etanercept.
- Subject had prosthetic joint infection within 5 years of screening or native joint
infection within 1 year of screening.
- Other criteria may apply.
We found this trial at
13
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