Last reviewed · How we verify
NCT04885829
Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers
Phase 1 trial testing Tocilizumab Prefilled Syringe in Rheumatoid Arthritis in 300 participants. Completed in 4 May 2023.
4 May 2023
Quick facts
| Lead sponsor | Syneos Health |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 31 May 2021 |
| Primary completion | 4 May 2023 |
| Estimated completion | 4 May 2023 |
| Sites | 4 locations across New Zealand, Australia, India |
Drugs / interventions tested
- Tocilizumab Prefilled Syringe — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Giant Cell Arteritis — all drugs for Giant Cell Arteritis →
Sponsor
Syneos Health — full company profile →
Who can join
Adults 18 to 50, any sex, with Rheumatoid Arthritis or Giant Cell Arteritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A single dose, two period trial where participants will be given either of 3 Tocilizumab product on Day 1 during period 1 and either one of the remaining 2 Tocilizumab products on Day 1 period 2. There will be at least 6 weeks (42 days) of wash out between subsequent two period dosing. The maximum flexibility allowed between subsequent periods will be up to 9 weeks (63 days). Names of the 3 tocilizumab products are DRL\_TC, RP and RMP. So if a participant receives DRL\_TC on Day 1 Period 1 then he/she will either receive RP/RMP on Day 1 Period 2.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04885829
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
- NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Syneos Health trials
Trials by the same sponsor.
- NCT07497503 — A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants · Phase 1 · not yet recruiting
- NCT05805618 — Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects · EARLY_PHASE1 · unknown
- NCT06435039 — A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers · Phase 1 · terminated
- NCT06170827 — Study to Evaluate the AIO-001 in Healthy Participants · Phase 1 · completed
- NCT05896969 — Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol · Phase 1 · completed
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 NCT04885829 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Syneos Health
- Last refreshed: 5 January 2024
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/NCT04885829.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing