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Monoclonal Antibodies

ABBV-154 for Rheumatoid Arthritis (AIM-RA Trial)

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks
Awards & highlights

AIM-RA Trial Summary

This trial is designed to study the safety and effectiveness of ABBV-154 in participants with moderately to severely active RA.

Eligible Conditions
  • Rheumatoid Arthritis

AIM-RA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response
Secondary outcome measures
Change in Clinical Disease Activity Index (CDAI) from Baseline
Change in Disease Activity Score (DAS) 28 (CRP) from Baseline
Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline
+6 more

AIM-RA Trial Design

5Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment2 Interventions
Participants in this group will receive placebo SC eow for 12 weeks in the placebo-controlled period and will be re-randomized in 1:1 ratio to receive ABBV-154 dose B or C respectively SC eow for 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.
Group II: Dose C of ABBV-154 EOWExperimental Treatment1 Intervention
Participants in this group will receive dose C of ABBV-154 SC eow for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.
Group III: Dose C of ABBV-154 E4WExperimental Treatment1 Intervention
Participants in this group will receive dose C of ABBV-154 SC every 4 weeks (e4w) for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.
Group IV: Dose B of ABBV-154Experimental Treatment1 Intervention
Participants in this group will receive dose B of ABBV-154 SC eow for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.
Group V: Dose A of ABBV-154Experimental Treatment1 Intervention
Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 12 weeks in the placebo-controlled period, 66 weeks in the long term extension (LTE) period 1 and 104 weeks in LTE period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
501,911 Total Patients Enrolled
48 Trials studying Rheumatoid Arthritis
113,147 Patients Enrolled for Rheumatoid Arthritis
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,625 Total Patients Enrolled
10 Trials studying Rheumatoid Arthritis
8,443 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over two decades of age accepted in this experiment?

"This clinical trial seeks individuals between the age of 18 and 75 to participate as potential candidates."

Answered by AI

Is this research currently recruiting participants?

"The clinicaltrials.gov page for this study confirms that it is not currently looking to recruit any more patients, despite originally being posted on June 2nd 2021 and last edited November 7th 2022. However, there are 378 other medical trials searching for participants presently."

Answered by AI

Are there multiple Canadian sites currently conducting this research experiment?

"There are 100 trial sites available, such as Altoona Ctr Clinical Res /ID# 230058 in Duncansville, The Arthritis & Diabetes Clinic, Inc. /ID# 228221 in Monroe, and Epic Medical Research /ID# 228097 in Red Oak."

Answered by AI

Has ABBV-154 received governmental authorization from the Food and Drug Administration?

"Given that it's a Phase 2 trial, the safety of ABBV-154 was rated with an intermediate score of 2. This is due to preliminary evidence suggesting its safe usage but no official confirmation on its efficacy."

Answered by AI

Is there an opportunity for me to join this research initiative?

"This clinical trial is recruiting 473 individuals with rheumatoid arthritis between 18 and 75 years old. Suitable candidates must exhibit at least 6 swollen joints (66 joint count), 6 tender joints (68 joint count) during screening, possess a clear diagnosis of RA in accordance to ACR/EULAR classification criteria for RA, have previously responded inadequately to biologic or targeted synthetic DMARDs treatments for RA, and be on a stable Methotrexate dose."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Texas
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
Arthritis and Rheumatology /ID# 228743
Arthritis Center of North GA /ID# 228769
Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried many different drugs and I just keep letting worse. I have had RA for almost 20 years. It keeps progressing with age and I have debilitating flares that can have me down in bed for weeks or months!
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04888585.
~123 spots leftby Apr 2025
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