A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
Purpose
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
- Rheumatoid Arthritis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Substudy 1: Lutikizumab Monotherapy |
Participants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B |
|
|
Placebo Comparator Substudy 1: Matching Placebo Monotherapy |
Participants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy. |
|
|
Experimental Substudy 2: Ravagalimab Monotherapy |
Participants will be randomized to receive Ravagalimab |
|
|
Placebo Comparator Substudy 2: Matching Placebo Monotherapy |
Participants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy |
|
|
Experimental SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy |
Participants will be randomized to be administered Lutikizumab and Ravagalimab doses |
|
|
Placebo Comparator Substudy 3: Matching Placebo Combination Therapy |
Participants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy |
|
Recruiting Locations
Tampa, Florida 33606
Site Coordinator
813-870-1292
More Details
- Status
- Recruiting
- Sponsor
- AbbVie