Rheumatoid Arthritis (RA) Clinical Trial
Official title:
Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Primary objective:
- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection
of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized
training by site personnel and review of written instructions
Secondary objectives:
- To evaluate the reliability and robustness of the VIBEX MTX device
- To evaluate the safety and local tolerance of an SC self-injection of MTX using the
VIBEX MTX device
- To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education
tools for SC self-injection
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05047341 -
A Study of Human Substance Balance and Biotransformation of [14C]SHR0302
|
Phase 1 | |
| Withdrawn |
NCT02786563 -
Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate
|
||
| Completed |
NCT03257852 -
A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
|
Phase 2 | |
| Completed |
NCT03660059 -
A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)
|
Phase 3 | |
| Recruiting |
NCT03971253 -
Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
|
||
| Not yet recruiting |
NCT05486715 -
Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients
|
||
| Completed |
NCT03682705 -
A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis
|
Phase 2 | |
| Active, not recruiting |
NCT04574492 -
A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis
|
||
| Active, not recruiting |
NCT02805010 -
Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously
|
Phase 1 | |
| Completed |
NCT01871961 -
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient
|
Phase 1 | |
| Active, not recruiting |
NCT04497597 -
A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis
|
||
| Terminated |
NCT02775656 -
UCB Cimzia Pregnancy Follow-up Study
|
||
| Completed |
NCT01173120 -
Methotrexate - Inadequate Response Device Sub-Study
|
Phase 3 | |
| Completed |
NCT03223012 -
Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
|
||
| Completed |
NCT03086343 -
A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
|
Phase 3 | |
| Terminated |
NCT01569152 -
Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)
|
Phase 2 | |
| Completed |
NCT02105129 -
A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523
|
Phase 1 | |
| Completed |
NCT01577563 -
Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).
|
N/A | |
| Completed |
NCT01618968 -
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
|
Phase 2 | |
| Completed |
NCT03339089 -
Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases
|