Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06972446 | RECRUITING | Rheumatoid Arthritis

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

AbbVie

Brief Summary:

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. 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.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

Lutikizumab

Placebo

Ravagalimab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
Actual Study Start Date : 2025-06-20
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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.
A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Location Details

NCT06972446

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Tekton Research - Fort Collins - East Harmony Road /ID# 272472

Fort Collins, Colorado, United States, 80528

RECRUITING

United States, Florida

Clinical Research Of West Florida - Phase I Unit /ID# 272428

Clearwater, Florida, United States, 33765

RECRUITING

United States, Florida

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755

Tampa, Florida, United States, 33606

RECRUITING

United States, Road cancer

AA Medical Research Center - Grand Blanc /ID# 272496

Tall white, Road cancer, United States, 48439

RECRUITING

United States, New Mexico

Albuquerque Center For Rheumatology /ID# 272301

Albuquerque, New Mexico, United States, 87102

RECRUITING

United States, Ohio

Paramount Medical Research and Consulting /ID# 272474

Middleburg Heights, Ohio, United States, 44130

RECRUITING

United States, Texas

Tekton Research - West Gate /ID# 272270

Austin, Texas, United States, 78745

RECRUITING

United States, Texas

Private Practice - Dr. Laila A. Hassan /ID# 272297

Houston, Texas, United States, 77089