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ABBV-154 for Rheumatoid Arthritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Rheumatoid ArthritisABBV-154 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 9 Secondary · Reporting Duration: At 12 weeks

At 12 weeks
Percentage of Participants Achieving American College of Rheumatology 20 % (ACR20) Response
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response
Percentage of Participants Achieving American College of Rheumatology 70 % (ACR70) Response
Percentage of Participants Achieving CR Defined by CDAI <= 2.8
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6
Percentage of Participants Achieving LDA Defined by CDAI <= 10
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2
Up to 12 weeks
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Text4Father
1
Novocure Optune
2
Mitapivat

Trial Design

5 Treatment Groups

Dose C of ABBV-154 EOW
1 of 5
Dose C of ABBV-154 E4W
1 of 5
Dose A of ABBV-154
1 of 5
Dose B of ABBV-154
1 of 5
Placebo
1 of 5

Experimental Treatment

473 Total Participants · 5 Treatment Groups

Primary Treatment: ABBV-154 · Has Placebo Group · Phase 2

Dose C of ABBV-154 EOW
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Dose C of ABBV-154 E4W
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Dose A of ABBV-154
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Dose B of ABBV-154
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
PlaceboExperimental Group · 2 Interventions: Placebo, ABBV-154 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 weeks

Who is running the clinical trial?

AbbVieLead Sponsor
833 Previous Clinical Trials
470,680 Total Patients Enrolled
46 Trials studying Rheumatoid Arthritis
112,687 Patients Enrolled for Rheumatoid Arthritis
ABBVIE INC.Study DirectorAbbVie
303 Previous Clinical Trials
117,966 Total Patients Enrolled
9 Trials studying Rheumatoid Arthritis
8,013 Patients Enrolled for Rheumatoid Arthritis

Eligibility Criteria

Age 18 - 75 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have ≥ 6 swollen joints and ≥ 6 tender joints at baseline.

Who else is applying?

What state do they live in?
Texas22.2%
Alabama22.2%
Georgia22.2%
Other33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Arthritis and Rheumatology /ID# 22874333.3%
Arthritis Center of North GA /ID# 22876933.3%
Buffalo Rheumatology and Medicine - Orchard Park /ID# 22871033.3%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%
Why did patients apply to this trial?
  • "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!"
References

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