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

Condition(s) studied

Investigational drug(s) / intervention(s)

Lutikizumab: Subcutaneous (SC) injection

Placebo: Subcutaneous (SC) injection

Ravagalimab: Subcutaneous (SC) injection

ABBV-8736: Subcutaneous (SC) injection

ABBV-701: Subcutaneous (SC) injection

ABBV-848: Oral Tablet

Adalimumab: Subcutaneous (SC) injection

Study 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 6 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. Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Substudy 4 will evaluate ABBV-8736 compared to Placebo. Substudy 5 will evaluate ABBV-701 compared to Placebo and Substudy 6 will be a proof of concept study of ABBV-848 in participants who are on a stable background of Methotrexate, with an Adalimumab reference arm. 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 up to 200 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.

Eligibility

Primary outcome measure(s)

• Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response — At 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.
• Substudy 6: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response — At Week 16
  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)

Trial sites (96)

+ 56 more sites — see the full list on the official registry below.

On this site

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