Drugs / Infliximab
Infliximab
DrugInfliximab is a tumor necrosis factor (TNF) blocker monoclonal antibody marketed as Remicade. It is used across immune-mediated diseases including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The FDA first approved infliximab in 1998.
- Trials
- 390
- Recruiting
- 32
- Completed
- 230
- With results
- 108
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1 | 1 | — | — | — | 13 | — | — | — | 14 |
| Phase 1/2 | 2 | — | — | 1 | — | 2 | 3 | 2 | 10 |
| Phase 2 | 7 | 3 | — | 3 | 25 | 10 | 4 | 4 | 56 |
| Phase 2/3 | 1 | — | — | — | 4 | 1 | 1 | — | 7 |
| Phase 3 | 2 | 1 | — | 1 | 67 | 9 | 2 | 7 | 89 |
| Phase 4 | 10 | 6 | 1 | 1 | 49 | 9 | 3 | 14 | 93 |
| Not applicable | 3 | 2 | — | 2 | 11 | 4 | 1 | 7 | 30 |
| Unknown | 6 | 1 | — | 3 | 61 | 4 | 1 | 15 | 91 |
Trials started per year
Conditions studied, by phase
| Condition | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn Disease | 1 | 1 | 1 | 2 | 16 | 27 | 11 | 33 | 92 |
| Arthritis, Rheumatoid | 2 | — | 6 | — | 23 | 24 | 4 | 26 | 85 |
| Colitis, Ulcerative | 2 | — | 1 | — | 10 | 17 | 6 | 19 | 55 |
| Inflammatory Bowel Diseases | 1 | 1 | 1 | — | 4 | 12 | 7 | 15 | 41 |
| Spondylitis, Ankylosing | 3 | — | 1 | 1 | 5 | 11 | 2 | 12 | 35 |
| Psoriasis | — | — | 2 | — | 10 | 4 | 1 | 10 | 27 |
| Arthritis, Psoriatic | — | — | 1 | — | 3 | 5 | — | 9 | 18 |
| Arthritis | — | — | 4 | 1 | 1 | — | — | 1 | 7 |
| COVID-19 | — | — | 2 | — | 2 | 1 | — | 2 | 7 |
| Inflammation | — | — | 5 | — | — | 2 | — | — | 7 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Merck Sharp & Dohme LLC | 46 | 16 |
| 2 | Centocor, Inc. | 23 | 18 |
| 3 | Celltrion | 10 | 7 |
| 4 | Pfizer | 10 | 1 |
| 5 | Sixth Affiliated Hospital, Sun Yat-sen University | 7 | 0 |
| 6 | Centocor Ortho Biotech Services, L.L.C. | 5 | 3 |
| 7 | Children's Hospital of Fudan University | 5 | 1 |
| 8 | Emory University | 5 | 0 |
| 9 | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | 5 | 1 |
| 10 | Massachusetts General Hospital | 5 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Infliximab | 390 |
| 2 | Adalimumab | 66 |
| 3 | Etanercept | 45 |
| 4 | golimumab | 30 |
| 5 | Methotrexate | 30 |
| 6 | Azathioprine | 28 |
| 7 | Certolizumab Pegol | 22 |
| 8 | vedolizumab | 21 |
| 9 | CT-P13 | 20 |
| 10 | Ustekinumab | 20 |
Evidence
- Results reported
- 47%108 of 230 completed
- Published
- 24.3%56 of 230 completed
- Primary endpoint met
- 54.9%28 of 51 analyses
- Median months to report
- 12
Documents disclosed
Trial profile
- Median enrollment
- 96
- Median duration
- 36months
- Countries
- 60
- Study sites
- 2901
Who is enrolled
Median enrollment by phase
- Phase 1
- 90
- Phase 1/2
- 12
- Phase 2
- 37
- Phase 2/3
- 50
- Phase 3
- 199
- Phase 4
- 86
- Not applicable
- 60
- Unknown
- 200
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Paris | France | 22 |
| 2 | Boston | United States | 21 |
| 3 | New York | United States | 20 |
| 4 | Houston | United States | 19 |
| 5 | Los Angeles | United States | 19 |
| 6 | Montreal | Canada | 18 |
| 7 | Toronto | Canada | 18 |
| 8 | Atlanta | United States | 17 |
| 9 | Lille | France | 17 |
| 10 | Brussels | Belgium | 16 |
Terminations
- Terminated
- 39
- Withdrawn
- 15
- Stopped for recruitment
- 6.2%24 of 390 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT06646016 Withdrawn | Withdrawn | Study Withdrawn by Sponsor prior to Enrollment. | 2027-02-19 |
| NCT04118556 Terminated | Terminated | Too slow recruitment | 2026-04-29 |
| NCT03937609 Terminated | Terminated | Slow recruitment | 2024-12-15 |
| NCT04530877 Withdrawn | Withdrawn | no funding | 2024-09-30 |
| NCT03088293 Withdrawn | Withdrawn | recruiting difficulties | 2024-07-31 |
| NCT04438382 Terminated | Terminated | Slow accrual | 2023-12-21 |
| NCT05168475 Terminated | Terminated | NIHR withdrawal of funding | 2023-11-29 |
| NCT04535518 Withdrawn | Withdrawn | lack of funding | 2022-09-30 |
| NCT03100253 Terminated | Terminated | Slow recrutiment | 2021-12-31 |
| NCT03209232 Terminated | Terminated | Difficulty to recruit patients and as high dose infliximab for severe UC is now the rule rather than the exception | 2021-09-01 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: