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-LT
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-29
• 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