NCT01721057: RA-BUILD

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis

Completed Phase 3 Results posted Last updated 9 September 2019

What this trial tests

Phase 3 trial testing Placebo in Rheumatoid Arthritis in 684 participants. Completed in 1 December 2014.

Timeline

1 December 2012

Primary endpoint
1 September 2014

1 December 2014

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	684
Start date	1 December 2012
Primary completion	1 September 2014
Estimated completion	1 December 2014
Sites	147 locations across United States, Argentina, Australia, Belgium, Canada, Croatia, Czechia, Germany

Drugs / interventions tested

• Placebo
• Baricitinib (baricitinib) — full drug profile →
• cDMARD — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
  Time frame: Week 12
  ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS

Sponsor's own description

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR \[inadequate response\] participants) and who have not received a biologic disease-modifying antirheumatic drug (DMARD).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study.
   Dougados M, van der Heijde D, Chen YC, Greenwald M, et al · · 2017 · cited 277× · PMID 27689735 · DOI 10.1136/annrheumdis-2016-210094
2. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment.
   Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, et al · · 2019 · cited 190× · PMID 30219772 · DOI 10.3899/jrheum.171361
3. Cardiovascular Safety During Treatment With Baricitinib in Rheumatoid Arthritis.
   Taylor PC, Weinblatt ME, Burmester GR, Rooney TP, et al · · 2019 · cited 130× · PMID 30663869 · DOI 10.1002/art.40841
4. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database.
   Taylor PC, Takeuchi T, Burmester GR, Durez P, et al · · 2022 · cited 114× · PMID 34706874 · DOI 10.1136/annrheumdis-2021-221276
5. Inflammation and Bone Metabolism in Rheumatoid Arthritis: Molecular Mechanisms of Joint Destruction and Pharmacological Treatments.
   Maeda K, Yoshida K, Nishizawa T, Otani K, et al · · 2022 · cited 92× · PMID 35270012 · DOI 10.3390/ijms23052871
6. Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study.
   Takeuchi T, Genovese MC, Haraoui B, Li Z, et al · · 2019 · cited 59× · PMID 30194275 · DOI 10.1136/annrheumdis-2018-213271
7. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies.
   Taylor PC, Kremer JM, Emery P, Zuckerman SH, et al · · 2018 · cited 44× · PMID 29463520 · DOI 10.1136/annrheumdis-2017-212461
8. Safety profile of baricitinib in Japanese patients with active rheumatoid arthritis with over 1.6 years median time in treatment: An integrated analysis of Phases 2 and 3 trials.
   Harigai M, Takeuchi T, Smolen JS, Winthrop KL, et al · · 2020 · cited 37× · PMID 30784354 · DOI 10.1080/14397595.2019.1583711