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)

Brief summary

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors place the participants in 1 of 5 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Participants 18-75 years of age with moderate to severe RA will be enrolled. Around 425 participants will be enrolled in the study in approximately 270 sites worldwide. The study is 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 will be re-randomized to receive ABBV-154 in 2 different doses SC every other week (eow). Other participants will remain on their previous dose and dosing regimen of ABBV-154. 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, blood tests, checking for side effects and completing questionnaires.

Interventional study

Rheumatoid Arthritis (RA)
473 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
Yes, please contact me

Eligibility criteria

Participant attributes:
Male and Female


From 18 Years to 75 Years.

Inclusion Criteria:

- Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 American
College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
classification criteria for RA.

- Participant has >= 6 swollen joints (based on 66 joint count) and >=6 tender joints
(based on 68 joint count) at baseline.

- Participant must have had an inadequate response to at least one prior biologic and/or
targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for

- Participants must be on stable dose of methotrexate (MTX).

Exclusion Criteria:

- Participant discontinued prior adalimumab therapy due to intolerability or toxicity.

All the cities where the clinical studies are located

Edmonton - T5M 0H4
Sainte-foy - G1V 3M7
Trois-rivières - G8Z 1Y2
Saskatoon - S7K 3H3
Winnipeg - R3A 1M3