A Phase 3b/4 Study in Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-003351-37-BE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-08
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (DMARD) (synthetic or biologic).
Participants must have at least one of the following characteristics:
•Documented evidence of a VTE prior to this study
•At least 60 years of age or older
• A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m2), or
•Age 50 to less than 60 years AND BMI 25 to less than 30 kg/m2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2080
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 520

Exclusion Criteria

•Participants must not have any problems taking a tumor necrosis factor (TNF) inhibitor, baricitinib, the active substance, or any of the excipients listed in the SmPC Section 6.1.
•Participants must not be pregnant or breastfeeding.
•Participants must not have had more than one VTE.
•Participants must not have cancer.
•Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness. This is also applicable to patients with evidence of HIV infection and/or who are positive for anti-HIV antibodies.
•Participants must not have had a live vaccine within four weeks of study start.
•Participants must not have participated in any other clinical trial within four weeks of study randomisation
•Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of VTE.;Secondary Objective: •To compare baricitinib (combined dose groups) to TNF inhibitors with respect to the risk of key safety outcomes.<br>•To compare each baricitinib dose to TNF inhibitors with respect to the risk of key safety outcomes.;Primary end point(s): Time from first dose of study treatment to first event of Venous thromboembolism (VTE).;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated at week 12, week 28, week 52 and every 24 weeks thereafter.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time from first dose of study treatment (combined baricitinib doses compared to TNF inhibitors) to first event of:<br>Arterial thromboembolic event (ATE)<br>Major adverse cardiovascular events (MACE)<br>Malignancy (excluding Nonmelanoma skin cancer(NMSC))<br>Opportunistic infection<br>Serious infection<br><br>Time from first dose of study treatment (each individual baricitinib dose compared to TNF inhibitor) to first event<br>of:<br>VTE<br>ATE<br>MACE<br>Malignancy (excluding NMSC)<br>Opportunistic infection<br>Serious infection;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at week 12, week 28, week 52 and every 24 weeks thereafter (all visits after randomisation).