Phase 3
Completed N=2,877
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01885078 ↗Enrolled (actual)
2,877
Serious AEs
23.9%
Results posted
Feb 2022
Primary outcomePrimary: Number of Participants Who Experienced Adverse Events (AEs) or Serious AE — 234; 1532; 270; 315 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 investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study.
The study provides 7 years of additional treatment with baricitinib.
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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Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate.
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Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis.
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Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis up to 6.5 years of treatment: results of a long-term study.
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Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Adverse Events (AEs) or Serious AE |
234; 1532; 270; 315; 112; 517 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20 |
67.3; 65.6; 60.4; 56.0; 50.5; 43.1 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20 |
67.3; 65.6; 60.4; 56.0; 50.5; 43.1 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20 |
67.3; 65.6; 60.4; 56.0; 50.5; 43.1 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50 |
59.9; 52.7; 44.4; 43.2; 37.6; 32.1 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50 |
59.9; 52.7; 44.4; 43.2; 37.6; 32.1 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50 |
59.9; 52.7; 44.4; 43.2; 37.6; 32.1 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70 |
48.2; 39.1; 28.4; 28.4; 23.8; 18.2 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70 |
48.2; 39.1; 28.4; 28.4; 23.8; 18.2 | — |
| SECONDARY Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70 |
48.2; 39.1; 28.4; 28.4; 23.8; 18.2 | — |
| SECONDARY Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2 |
61.1; 58.9; 46.7; 50.0; 44.6; 34.3 | — |
| SECONDARY Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2 |
61.1; 58.9; 46.7; 50.0; 44.6; 34.3 | — |
| SECONDARY Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2 |
61.1; 58.9; 46.7; 50.0; 44.6; 34.3 | — |
| SECONDARY Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6 |
51.1; 44.0; 36.1; 37.7; 29.7; 26.6 | — |
| SECONDARY Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6 |
51.1; 44.0; 36.1; 37.7; 29.7; 26.6 | — |
| SECONDARY Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6 |
51.1; 44.0; 36.1; 37.7; 29.7; 26.6 | — |
| SECONDARY Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2 |
48.7; 41.3; 36.1; 32.5; 23.8; 21.9 | — |
| SECONDARY Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2 |
48.7; 41.3; 36.1; 32.5; 23.8; 21.9 | — |
| SECONDARY Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2 |
48.7; 41.3; 36.1; 32.5; 23.8; 21.9 | — |
| SECONDARY Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6 |
31.3; 23.9; 22.5; 19.4; 11.9; 8.8 | — |
| SECONDARY Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6 |
31.3; 23.9; 22.5; 19.4; 11.9; 8.8 | — |
| SECONDARY Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6 |
31.3; 23.9; 22.5; 19.4; 11.9; 8.8 | — |
| SECONDARY Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response |
26.5; 17.7; 13.6; 14.2; 6.9; 7.3 | — |
| SECONDARY Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response |
26.5; 17.7; 13.6; 14.2; 6.9; 7.3 | — |
| SECONDARY Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response |
26.5; 17.7; 13.6; 14.2; 6.9; 7.3 | — |
| SECONDARY Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS) |
1.64; 2.18; 1.32; 1.58 | — |
| SECONDARY Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS) |
1.64; 2.18; 1.32; 1.58 | — |
| SECONDARY Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS) |
1.64; 2.18; 1.32; 1.58 | — |
| SECONDARY Percentage of Participants With mTSS Change ≤0 |
1.7; 0.6; 0; 0.5; 0 | — |
| SECONDARY Percentage of Participants With mTSS Change ≤0 |
1.7; 0.6; 0; 0.5; 0 | — |
| SECONDARY Percentage of Participants With mTSS Change ≤0 |
1.7; 0.6; 0; 0.5; 0 | — |
| SECONDARY Change From Baseline of Originating Study in Joint Space Narrowing at Year 1 |
— | — |
| SECONDARY Change From Baseline of Originating Study in Joint Space Narrowing at Year 3 |
0.45; 0.72; 0.54; 0.44; 0.52 | — |
| SECONDARY Change From Baseline of Originating Study in Joint Space Narrowing at Year 5 |
0.59; 1.00; 0.68; 0.60 | — |
| SECONDARY Change From Baseline of Originating Study in Duration of Morning Stiffness |
-111.45; -82.48; -88.37; -91.57; -92.75; -45.89 | — |
| SECONDARY Change From Baseline of Originating Study in Duration of Morning Stiffness |
-111.45; -82.48; -88.37; -91.57; -92.75; -45.89 | — |
| SECONDARY Change From Baseline of Originating Study in Duration of Morning Stiffness |
-111.45; -82.48; -88.37; -91.57; -92.75; -45.89 | — |
| SECONDARY Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores |
0.35; 0.26; 0.19; 0.20; 0.21; 0.22 | — |
| SECONDARY Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores |
0.35; 0.26; 0.19; 0.20; 0.21; 0.22 | — |
| SECONDARY Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores |
0.35; 0.26; 0.19; 0.20; 0.21; 0.22 | — |
| SECONDARY Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) |
31.13; 23.93; 13.82; 19.34; 26.19; 23.57 | — |
| SECONDARY Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) |
31.13; 23.93; 13.82; 19.34; 26.19; 23.57 | — |
| SECONDARY Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) |
31.13; 23.93; 13.82; 19.34; 26.19; 23.57 | — |
| SECONDARY Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10 |
61.6; 61.1; 51.5; 54.6; 44.6; 35.4 | — |
| SECONDARY Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10 |
61.6; 61.1; 51.5; 54.6; 44.6; 35.4 | — |
| SECONDARY Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10 |
61.6; 61.1; 51.5; 54.6; 44.6; 35.4 | — |
| SECONDARY Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤ 2.8 |
44.9; 28.3; 21.9; 25.1; 16.8; 13.5 | — |
| SECONDARY Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8 |
33.9; 25.0; 19.5; 22.4; 15.8; 12.8 | — |
| SECONDARY Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8 |
33.9; 25.0; 19.5; 22.4; 15.8; 12.8 | — |
| SECONDARY Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22 |
65.2; 58.5; 51.5; 51.4; 50.5; 39.4 | — |
| SECONDARY Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22 |
65.2; 58.5; 51.5; 51.4; 50.5; 39.4 | — |
| SECONDARY Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22 |
65.2; 58.5; 51.5; 51.4; 50.5; 39.4 | — |
| SECONDARY Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3 |
62.8; 53.4; 46.7; 46.2; 46.5; 35.0 | — |
| SECONDARY Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3 |
62.8; 53.4; 46.7; 46.2; 46.5; 35.0 | — |
| SECONDARY Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3 |
62.8; 53.4; 46.7; 46.2; 46.5; 35.0 | — |
| SECONDARY Change From Baseline of Originating Study in Bone Erosion Score |
1.04; 1.18; 0.65; 0.98 | — |
| SECONDARY Change From Baseline of Originating Study in Bone Erosion Score |
1.04; 1.18; 0.65; 0.98 | — |
| SECONDARY Change From Baseline of Originating Study in Bone Erosion Score |
1.04; 1.18; 0.65; 0.98 | — |
| SECONDARY Healthcare Resource Utilization |
3134; 11108; 2160; 4573; 2380; 5410 | — |
| SECONDARY Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11 |
61.3; 61.2; 51.5; 53.3; 46.5; 35.4 | — |
| SECONDARY Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11 |
61.3; 61.2; 51.5; 53.3; 46.5; 35.4 | — |
| SECONDARY Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11 |
61.3; 61.2; 51.5; 53.3; 46.5; 35.4 | — |
| SECONDARY Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3 |
34.8; 24.7; 20.7; 21.3; 13.9; 11.3 | — |
| SECONDARY Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3 |
34.8; 24.7; 20.7; 21.3; 13.9; 11.3 | — |
| SECONDARY Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3 |
34.8; 24.7; 20.7; 21.3; 13.9; 11.3 | — |
| SECONDARY Percentage of Participants With Relapse Event During the 96-Week Step-Down Period |
11.8; 5.4; 26.0; 12.5; 31.0; 18.2 | — |
Eligibility Criteria
Inclusion Criteria
- Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)
Exclusion Criteria
- Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
- Have a known hypersensitivity to baricitinib or any component of this investigational product
- Had investigational product permanently discontinued at any time during a previous baricitinib study
- Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
- Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
Data sourced from ClinicalTrials.gov (NCT01885078) 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.