Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814627
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-04-04
Brief Title:
Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3b4 Randomized Double-Blind Double Dummy Active Comparator-Controlled Study Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor SELECT- SWITCH
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SELECT- SWITCH
Brief Summary:
Rheumatoid Arthritis RA is a chronic inflammatory disease causing pain stiffness swelling and loss of joint function This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate MTX Adverse events and change in disease activity will be assessed
Upadacitinib is an approved drug for the treatment of RA This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab Study doctors put the participants in 1 of the 2 groups called treatment arms randomly to receive either upadacitinib or adalimumab There is 1 in 2 chance that participants will receive adalimumab Each group consists of 2 periods Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world
Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1 Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments checking for side effects and completing questionnaires
Upadacitinib is an approved drug for the treatment of RA This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab Study doctors put the participants in 1 of the 2 groups called treatment arms randomly to receive either upadacitinib or adalimumab There is 1 in 2 chance that participants will receive adalimumab Each group consists of 2 periods Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world
Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1 Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502578-18-00 | OTHER | EU CT | None |