Study of Targeted Therapies for Rheumatoid Arthritis

This study is for people with moderately to severely active Rheumatoid Arthritis (RA), a chronic disease causing joint pain and swelling. It's testing two targeted therapies, lutikizumab and ravagalimab, to see how well and safely they work. You might receive lutikizumab alone, ravagalimab alone, a combination of both, or a placebo (an inactive substance that looks like the study treatment). To join, you must be at least 18 years old and have previously tried at least one other RA treatment for at least three months, or stopped it due to side effects. The study will measure how many participants have a 50% improvement in their RA symptoms after 12 weeks, and track any side effects for about 22 weeks.

Study design
This interventional study plans to enroll 180 participants. It includes three substudies comparing active treatments to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 22 weeks.

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NCT06972446

A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~180 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:LutikizumabPlaceboRavagalimab

At a glance

Recruiting sites
96 of 104 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Measured over At Week 12
+1 more outcome measured
Rheumatoid Arthritis
104 sites across 48 states
Texas16
Florida11
Puerto Rico7
California6
Illinois5
North Carolina3
Hungary3
Spain3
  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

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Eligibility criteria

Inclusion

At any time prior to the Screening Visit, participant must have been treated for \> or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.
Participant must be on a stable dose of methotrexate (MTX)

Exclusion

Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.
History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.
  • Percentage of Participants With an American College of Rheumatology 50% (ACR50) ResponseAt 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)

  • Number of Participants with Adverse Events (AEs)Up to Approximately Week 22

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.