Sjögren's syndrome (disorder)
TRACTISS: A randomized double blind placebo controlled clinical TRial of anti-B-Cell Therapy In patients with primary Sjögren’s Syndrome
Year Started: 2011
A multi-centre, randomised, double-blind, placebo controlled, phase III trial in patients with primary Sjögren’s syndrome with fatigue, oral dryness. Males and female recruited between 18 and 80 years of age with an AECG diagnosis of Primary Sjögren’s Syndrome. Biological samples (salivary gland tissue & fluids) collected at multiple timepoints (details available on request) over a 48 week follow-up period; please note figures for baseline samples are represented (availability of samples from other timepoints on request). Recruitment status for this study is 136 patients.
- Access:
- Closed to access
- Type:
- Clinical Trial
- Status:
- Completed
- Consent restrictions:
- Xenograft restriction
| Associated Data Type | Procurement Timeframe |
|---|---|
| Biomarker datasets | 0 - 3 months |
| Clinical records | 3 - 6 months |
| Followup records | 3 - 6 months |
| Pathology records | 0 - 3 months |
| Physiological/biochemical measurements | 3 - 6 months |
| Treatment records | 3 - 6 months |
Unknown
Data not recorded
101 - 500 donors
| Material Type | Extraction Procedure | Storage Temperature | Preservation Type | Macroscopic Assessment | % of Sample Set |
|---|---|---|---|---|---|
| Peripheral blood mononuclear cells (PBMC) | Liquid nitrogen liquid phase | N/A | Affected | 75% -99% | |
| RNA | -60°C to -85°C | N/A | Affected | 11 - 25% | |
| Saliva | -60°C to -85°C | N/A | Affected | 11 - 25% | |
| Serum | -60°C to -85°C | N/A | Affected | 75% -99% | |
| Tissue specimen | Surgical procedure (procedure) | RT | Paraffin | Affected | 11 - 25% |