Trials / Completed
CompletedNCT02722044
Usability of an AI for M923 in Subjects With Moderate to Severe RA
An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Momenta Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | M923 | Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) |
| DEVICE | Autoinjector | Subcutaneous administration |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2017-02-21
- Completion
- 2017-02-21
- First posted
- 2016-03-29
- Last updated
- 2018-05-16
- Results posted
- 2018-05-01
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02722044. Inclusion in this directory is not an endorsement.