Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-04-08 @ 9:35 AM
Study NCT ID:
NCT02640612
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of patients with drug-related adverse events (AEs) during the treatment phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI 695501 by evaluation of:
* the change from Baseline in DAS28 (ESR) at Week 48
* the proportion of patients meeting American College of Rheumatology 20% (ACR20) response criteria at Week 48
* the proportion of patients who meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition of remission at Week 48
* the proportion of patients with EULAR response (good response, moderate response, or no response) at Week 48.
* the change from Baseline in DAS28 (ESR) at Week 48
* the proportion of patients meeting American College of Rheumatology 20% (ACR20) response criteria at Week 48
* the proportion of patients who meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition of remission at Week 48
* the proportion of patients with EULAR response (good response, moderate response, or no response) at Week 48.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-002634-41 | EUDRACT_NUMBER | None | View |