Trials / Completed
CompletedNCT02746380
A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 383 (actual)
- Sponsor
- LG Life Sciences · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LBAL | Adalimumab |
| DRUG | Humira® | Adalimumab |
Timeline
- Start date
- 2016-04-13
- Primary completion
- 2017-07-14
- Completion
- 2018-02-23
- First posted
- 2016-04-21
- Last updated
- 2021-03-15
Locations
2 sites across 2 countries: Japan, South Korea
Source: ClinicalTrials.gov record NCT02746380. Inclusion in this directory is not an endorsement.