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NCT04888585 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
A Phase 2 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 2
- Development phase
- 473
- Enrollment target
NCT04888585 is a Phase 2 study that was terminated before completion, run by AbbVie. The registered enrollment target is 473 participants.
The verdict
NCT04888585, a Phase 2 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 473 participants
- Enrollment target
Study Summary
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluated how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity were assessed. ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors placed the participants in 1 of 5 treatment groups or arms; each arm received a different treatment. There was a 1 in 5 chance that participants were assigned to placebo. Participants 18-75 years of age with moderate to severe RA were enrolled. Around 425 participants were to be enrolled in the study at approximately 270 sites worldwide. The study was comprised of a 12 week placebo-controlled period, a double-blind long term extension (LTE) period 1 of 66 weeks, a LTE period 2 of 104 weeks and a follow-up visit 70 days after the last dose of the study drug. In the LTE period 1, participants in the placebo group were re-randomized to receive ABBV-154 at 1 of 2 different doses SC every other week (EOW). Other participants remained on their previous dose and dosing regimen of ABBV-154. There may have been a higher treatment burden for participants in this trial compared to their standard of care. Participants attended regular visits during the study at a hospital or clinic. The effect of the treatment was checked by medical assessments, blood tests, and side effects, and completing questionnaires.
Interventions
- DRUG Placebo
- DRUG ABBV-154
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 473 participants |
| Start Date | 2021-06-23 |
| Est. Completion | 2023-08-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04888585
The ClinicalTrials.gov registry entry for NCT04888585 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 473 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04888585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04888585 about?
NCT04888585 is a clinical study titled "Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)". Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluated how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity wer...
What is the current status of trial NCT04888585?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 473 participants. The study started on 2021-06-23. Estimated completion is 2023-08-04.
What interventions are being tested in trial NCT04888585?
The interventions under investigation include: Placebo (DRUG), ABBV-154 (DRUG).
Who is sponsoring clinical trial NCT04888585?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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