A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
CompletedPhase 2Results postedLast updated 19 July 2021
What this trial tests
Phase 2 trial testing ABBV-3373 in Rheumatoid Arthritis (RA) in 48 participants. Completed in 26 August 2020.
Adults 18 to 75, any sex, with Rheumatoid Arthritis (RA). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])Primary· Baseline and Week 12
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale \[VAS\] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Group
Value
95% CI
Adalimumab
-2.51
± 0.293
ABBV-3373
-2.65
± 0.215
Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)Secondary· Baseline and Week 12
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Group
Value
95% CI
Adalimumab
-26.30
± 2.656
ABBV-3373
-27.99
± 1.955
Change From Baseline in Simplified Disease Activity Index (SDAI)Secondary· Baseline and Week 12
The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal \< 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Group
Value
95% CI
Adalimumab
-27.42
± 2.659
ABBV-3373
-28.50
± 1.961
Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])Secondary· Baseline and Week 12
The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.
Group
Value
95% CI
Adalimumab
-2.55
± 0.344
ABBV-3373
-2.76
± 0.254
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12Secondary· Week 12
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.
Group
Value
95% CI
Adalimumab
58.8
39.2 – 78.5
ABBV-3373
54.8
40.1 – 69.5
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12Secondary· Baseline and Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
1. ≥ 50% improvement in 68-tender joint count;
2. ≥ 50% improvement in 66-swollen joint count; and
3. ≥ 50% improvement in at least 3 of the 5 following parameters:
* Physician global assessment of disease activity
* Patient global assessment of disease activity
* Patient assessment of pain
* Health Assessment Questionnaire - Disability Index (HAQ-DI)
* High-sensitivity C-reactive protein (hsCRP).
Group
Value
95% CI
Adalimumab
64.7
45.6 – 83.8
ABBV-3373
51.6
36.8 – 66.4
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 19 July 2021
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