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)
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.
Timeline
- Start
- 2021-06-23
- Primary completion
- 2022-08-25
- Completion
- 2023-08-04
Outcome
Met primary endpoint
Stopped (Business): “Business decision”
registry analysis (superiority test); Period 1 (Placebo-Controlled Period) Placebo vs Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW; p <0.001; Response Rate Difference 21.2 NCT04888585 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADALIMUMAB FOSIMDESONIDE | Unknown | 40 mg | Subcutaneous |
| Subject | ADALIMUMAB FOSIMDESONIDE | Unknown | 150 mg | Subcutaneous |
| Subject | ADALIMUMAB FOSIMDESONIDE | Unknown | 340 mg | Subcutaneous |