Phase 3
Completed N=588
A Study in Participants With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01711359 ↗Enrolled (actual)
588
Serious AEs
7.2%
Results posted
Aug 2017
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) — 61.9; 76.7; 78.1 Percent of participants
◆ Published Evidence
Highly cited
158citations · ~40 / year
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.
Summary
The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).
Linked Publications (5)
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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.
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Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy.
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Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis.
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Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND.
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Robust analyses for radiographic progression in rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) |
55.7; 73.0; 72.6 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) |
55.7; 73.0; 72.6 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
-0.73; -1.01; -0.92 | — |
| SECONDARY Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP) |
-2.01; -2.74; -2.82 | — |
| SECONDARY Change From Baseline in the Modified Total Sharp Score (mTSS) |
0.64; 0.43; 0.32 | — |
| SECONDARY Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3 |
10.5; 22.0; 22.8 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
32.9; 54.7; 60.0; 43.3; 59.7; 63.3 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
15.7; 30.8; 33.5; 21.4; 42.1; 39.5 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Score |
-22.12; -28.20; -29.86; -21.95; -28.94; -30.72 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) |
-2.20; -2.76; -3.06; -2.32; -2.84; -3.22 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission |
5.7; 13.8; 14.4; 8.6; 18.9; 16.3 | — |
| SECONDARY Change From Baseline in Joint Space Narrowing and Bone Erosion Scores |
0.15; 0.08; 0.05; 0.23; 0.26; 0.08 | — |
| SECONDARY Change From Baseline in Duration of Morning Joint Stiffness |
-40.0; -55.0; -60.0 | — |
| SECONDARY Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS) |
-2.2; -3.0; -3.0; -2.3; -2.9; -3.0 | — |
| SECONDARY Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS) |
-2.8; -3.9; -3.9; -3.0; -3.9; -4.1 | — |
| SECONDARY Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) |
3.4; 5.9; 4.6; 2.4; 5.8; 5.0 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores |
0.142; 0.197; 0.194; 0.138; 0.186; 0.185 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) |
14.5; 24.1; 21.4; 13.6; 24.5; 24.5 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores |
9.3; 13.0; 12.3; 9.1; 11.3; 12.6 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores |
-3.6; -8.7; -7.6; -3.0; -8.4; -7.3 | — |
| SECONDARY Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib |
135 | — |
| SECONDARY Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib |
1280 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of adult-onset rheumatoid arthritis (RA) as defined by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
- Have documented history of positive rheumatoid factor and/or cyclic citrullinated peptide (CCP) antibody test
- 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 ≥1.2 times the upper limit of normal (ULN)
- Have had limited or no treatment with methotrexate (MTX)
Exclusion Criteria
- Have received conventional disease-modifying antirheumatic drugs (DMARDs) other than MTX (eg, gold salts, cyclosporine, leflunomide, azathioprine, hydroxychloroquine, sulfasalazine or any other immunosuppressives)
- Are currently receiving corticosteroids at doses >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
- Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
- 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 a 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 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, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically signifi
Data sourced from ClinicalTrials.gov (NCT01711359) and the linked publication. 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. Informational only — not medical advice.