| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04870203 | Combination of Baricitinib and Anti-TNF in Rheumatoid Arthritis | PHASE3 | ACTIVE NOT_RECRUITING | 160 | — | — | Jul 15, 2021 | Mar 1, 2027 | Mar 17, 2026 | 36 | France, Monaco |
| NCT02265705 | A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA) | PHASE3 | COMPLETED | 290 | — | — | Oct 1, 2014 | May 1, 2017 | Sep 11, 2019 | 30 | Argentina, Brazil +1 |
| NCT01885078 | An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis | PHASE3 | COMPLETED | 2,877 | — | — | Jun 27, 2013 | Nov 12, 2020 | Apr 25, 2022 | 408 | United States, Argentina +36 |
| NCT01721044 | A Moderate to Severe Rheumatoid Arthritis Study | PHASE3 | COMPLETED | 527 | — | — | Jan 1, 2013 | Sep 1, 2014 | Sep 18, 2019 | 103 | United States, Argentina +20 |
| NCT01721057 | A Study in Moderate to Severe Rheumatoid Arthritis Participants | PHASE3 | COMPLETED | 684 | — | — | Dec 1, 2012 | Dec 1, 2014 | Sep 18, 2019 | 147 | United States, Argentina +21 |
| NCT01711359 | A Study in Participants With Moderate to Severe Rheumatoid Arthritis | PHASE3 | COMPLETED | 588 | — | — | Nov 1, 2012 | Aug 1, 2015 | Sep 19, 2019 | 154 | United States, Argentina +17 |
| NCT01710358 | A Study in Moderate to Severe Rheumatoid Arthritis | PHASE3 | COMPLETED | 1,307 | — | — | Oct 1, 2012 | Sep 1, 2015 | Sep 18, 2019 | 213 | United States, Argentina +26 |
in each treatment group (COMBI group (anti-TNF therapy + baricitinib) vs. MONO group (baricitinib conventional therapy)).
in each treatment group (COMBI group (anti-TNF therapy + baricitinib) vs. MONO group (baricitinib conventional therapy)).
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%. An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. 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), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
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), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
| Arm | Type | Description |
|---|---|---|
| Period A : baricitinib + anti-TNF | EXPERIMENTAL | - |
| Period A : baricitinib + placebo | PLACEBO_COMPARATOR | - |
| Period B : baricitinib + anti-TNF | EXPERIMENTAL | - |
| Period B : baricitinib | ACTIVE_COMPARATOR | - |
| Baricitinib | EXPERIMENTAL | 4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks. Participants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52. Participants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline. |
| 4 milligram (mg) Baricitinib | EXPERIMENTAL | 4 mg Baricitinib administered orally once daily. Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study. |
| 2 mg Baricitinib | EXPERIMENTAL | 2 mg Baricitinib administered orally once daily. Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study. |
| 2 mg Baricitinib Step-down | EXPERIMENTAL | 2 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study. |
| 4 mg Baricitinib Step-down | EXPERIMENTAL | 4 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study. |
| Baricitinib 2 mg | EXPERIMENTAL | Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. |
| Baricitinib 4 mg | EXPERIMENTAL | Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. |
| Baricitinib + MTX | EXPERIMENTAL | Baricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. |
| MTX | ACTIVE_COMPARATOR | MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly. |
| Adalimumab | ACTIVE_COMPARATOR | Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study. |
| Name | Type | Description |
|---|---|---|
| baricitinib treatment | DRUG | 4 mg daily during 12 months |
| anti-TNF therapy | DRUG | adalimumab at 40 mg every 2 weeks or etanercept 50 mg per week according to treatments history |
| Placebo | DRUG | 40 mg every 2 weeks during 6 months only during Period A |
| Baricitinib | DRUG | Administered orally |
| cDMARD | DRUG | Participants will continue to take background cDMARD therapy throughout study. |
| Methotrexate | DRUG | Administered orally |
| Baricitinib Placebo | DRUG | Baricitinib placebo administered orally once daily. |
| MTX Placebo | DRUG | MTX placebo administered orally once weekly. |
| Folic Acid | DRUG | Administered orally every day |
| Adalimumab | DRUG | Administered SC |
| Adalimumab Placebo | DRUG | Adalimumab placebo administered SC. |
Inclusion Criteria: * Male or female; * Age between 18 and 65 years-old; * Adult patient with a diagnosis of RA as defined by the ACR/EULAR 2010 criteria for the classification of RA; * Patient who presents an inadequate response to at least one bDMARD or tsDMARD for at least 12 weeks prior to stud...