Phase 3
N=684
A Study in Moderate to Severe Rheumatoid Arthritis Participants
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01721057 ↗Enrolled (actual)
684
Serious AEs
4.1%
Results posted
Jun 2017
Primary outcome: Primary: Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) — 39.5; 65.9; 61.7 percentage of participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Baricitinib (Drug); cDMARD (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) |
39.5; 65.9; 61.7 | 0.001 sig |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
-0.30; -0.52; -0.52 | — |
| SECONDARY Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP) |
-1.05; -1.83; -1.91 | — |
| SECONDARY Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3 |
0.9; 9.2; 8.8 | — |
| SECONDARY Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries |
60.0; 44.4; 34.6 | — |
| SECONDARY Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries |
4.2; 3.5; 3.4 | — |
| SECONDARY Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries |
4.5; 4.0; 4.0 | — |
| SECONDARY Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries |
4.7; 3.9; 3.8 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
12.7; 33.6; 33.5; 21.5; 41.5; 44.1 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
3.1; 17.9; 18.1; 7.9; 25.3; 24.2 | — |
| SECONDARY Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) Score |
-14.29; -20.99; -23.18 | — |
| SECONDARY Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score |
-14.55; -21.87; -23.78 | — |
| SECONDARY Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR) |
-1.16; -1.89; -1.97 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission |
0.4; 7.0; 6.6 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores. |
7.6; 8.7; 8.8; 7.8; 9.2; 9.7 | — |
| SECONDARY Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) |
3.3; 3.6; 3.3; 2.7; 3.0; 3.3 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores |
0.054; 0.117; 0.109; 0.051; 0.113; 0.129 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) |
5.7; 13.4; 11.5; 8.4; 13.1; 10.4 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores |
2.6; -6.3; 2.5; -2.1; -3.8; 4.0 | — |
| SECONDARY Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104 |
70.2; 138 | — |
| SECONDARY Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104 |
637; 1210 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
- Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
- Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥ (greater than or equal to) 1.2 times the upper limit of normal (ULN)
- Have had an insufficient response or are intolerant to conventional disease-modifying antirheumatic drugs (cDMARDs) and either:
- Have had regular use of a cDMARD for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry
- For participants not receiving a cDMARD at the time of entry, the investigator will document in the participant's history that the participant had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD
Exclusion Criteria
- Are currently receiving corticosteroids at doses > (greater than)10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
- Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
- Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
- Have ever received any biologic DMARD
- Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
- Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
- Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
- Have active fibromyalgia that, in the investigator's opinion, would make it difficult to appropriately assess RA activity for the purposes of this study
- Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis,spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout(participants with secondary Sjogren's syndrome are not excluded.)
- Have a diagnosis of Felty's syndrome
- Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
- Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
- Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
- Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of 1.5 times the ULN or the most recent available total bilirubin >/=1.5 times the ULN
- Have a history of, lymphoprolife
Data sourced from ClinicalTrials.gov (NCT01721057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.