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NCT05913817: EASE PAIN
The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.
trial testing AVT02 (Alvotech Biosimilar to Adalimumab) in Crohn Disease in 324 participants. Completed in 25 August 2025.
31 July 2025
Quick facts
| Lead sponsor | Jamp Pharma Corporation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 324 |
| Start date | 9 January 2023 |
| Primary completion | 31 July 2025 |
| Estimated completion | 25 August 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- AVT02 (Alvotech Biosimilar to Adalimumab) — full drug profile →
Conditions studied
- Crohn Disease — all drugs for Crohn Disease →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →
Sponsor
Jamp Pharma Corporation — full company profile →
Who can join
18 and older, any sex, with Crohn Disease or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the Phase IV study is to investigate the effects of both Volume and Citrate on Injection Site Pain (ISP), adherence, patient satisfaction, Quality of Life, and Disease Assessment in the Canadian Adalimumab Market. The phase IV study is an observational, pan-Canadian, multidisciplinary study aiming to enroll 600 patients across 50-70 sites across 3 different Therapeutic Areas (GI, Rheum, Derm).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Anti-TNFα in inflammatory bowel disease: from originators to biosimilars.
Zeng Z, Lin H, Jiang M, Yuan J, et al · · 2024 · cited 8× · PMID 39114362 · DOI 10.3389/fphar.2024.1424606 -
Evaluation of Injection Site Pain and Adherence in Patients Transitioning from a High to Low Volume Adalimumab Formulation (AVT02, Simlandi®) Across Multiple Indications (EASE PAIN).
Shahrokh DK, Vender RB, Lynde CW, Rao J, et al · · 2026 · PMID 41963765 · DOI 10.1007/s40744-026-00846-1
Verify or expand the search:
- PubMed search for NCT05913817
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
- NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
- NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
- NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05913817 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jamp Pharma Corporation
- Last refreshed: 17 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05913817.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing