WHO ICTRP trial
A 48-week study of etanercept (enbrel ®) vs. sulfasalazine followed by an…
EUCTR2005-002320-34-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2005-002320-34-DE |
|---|---|
| Public title | A 48-week study of etanercept (enbrel ®) vs. sulfasalazine followed by an open-label extension with etanercept up to week 540 in early axial spondyloarthritis (ESTHER) |
| Scientific title | Randomized controlled 12 months trial with etanercept (enbrel ®) vs. sulfasalazine followed by an open-label extension with etanercept up to week 540 in early axial spondyloarthritis with focus on improvement of acute inflammatory lesions as detected by MRI (ESTHER) - ESTHER |
| Primary sponsor | Charité Universitätsmedizin Berlin |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Germany |
| Conditions | The proposed study is designed to get first data on efficacy and safety of etanercept in the treatment of patients with moderate to severe early axial Spondyloarthritis (SpA) with disease duration of less than 5 years compared to… |
| Interventions | Trade Name: Enbrel Product Name: Enbrel Product Code: WAY-143050 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Etanercept Concentration unit: mg milligram(s) Concentration type: equal Concentration number… |
| Registration date | May 16, 2006 |
| Target size | 80 |
| Secondary IDs | M01 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: