| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN22288225 |
| Date ISRCTN assigned | 04/09/2007 |
| Local reference number(s) | BiP-01 |
| Public title | Human stress protein (immunoglobulin Binding Protein [BiP]) for the treatment of rheumatoid arthritis |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Rheumatoid arthritis |
| Study hypothesis | BiP will safely suppress inflammatory joint synovitis in patients with rheumatoid arthritis. |
| Design/methodology | Randomised, placebo-controlled, single escalating dose in patients with Rheumatoid Arthritis (RA) |
| Research ethics review | Pending as of 27/07/2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Active RA |
| Participants - exclusion criteria | 1. Intercurrent serious disease
2. Malignancy
3. Pregnant/lactating |
| Patient information material |
|
| Anticipated start date | 01/06/2008 |
| Anticipated end date | 01/06/2011 |
| Status of trial | Ongoing |
| Target number of participants | 32 |
| Interventions | This is a single escalating dose placebo-controlled randomised clinical trial of the efficacy of BiP administered intravenously for the treatment of patients with active rheumatoid arthritis have failed methotrexate therapy.
There are four treatment groups. In each treatment group six patients will be randomly allocated to active treatment and two to placebo. Patients will receive only a single dose. Escalation to the next highest dose will only take place four weeks after safety evaluation from the last visit of the last patient in the previous group. The doses of BiP to be administered are 1, 2.5, 10 or 100 mg per patient. Patients will be monitored closely during the first 24 hours after infusion in a clinical research facility. They will thereafter be reviewed for safety and efficacy at weekly intervals up to four weeks. |
| Primary outcome measure(s) | The primary endpoint will be safety. A close watch will be kept on side-effects and in particular serious adverse events. The side-effects will be monitored by a safety committee consisting of two rheumatologists with expertise in this area but who are in no way connected to the trial.
The primary and secondary endpoints will be measured prior to the intravenous infusion, at the end of 24 hours and weekly thereafter to the fourth week. |
| Secondary outcome measure(s) | 1. Clinical efficacy as measured by the Americal College of Rheumatology (ACR) 20, ACR 50 and ACR 70 response criteria and the European League Against Rheumatism Disease Activity Score (EULAR DAS28)
2. Immunological measurements of immune responses such as T-cell proliferation to tuberculin Purified Protein Derivative (PPD), Phytohaemagglutinin (PHA) and BiP; the development of regulatory T-cells; and cytokine production.
The primary and secondary endpoints will be measured prior to the intravenous infusion, at the end of 24 hours and weekly thereafter to the fourth week. |
| Sources of funding | Immune Regulation Ltd (UK) |
| Sponsor name | King's College London Enterprises (UK) |
| Sponsor details | Capital House
Guy's Hospital
London
United Kingdom
SE1 9RT |
| Sponsor telephone | +44 (0)20 7188 5880 |
| Sponsor fax | +44 (0)20 7188 5883 |
| Sponsor email | gabriel.panayi@kcl.ac.uk |
| Sponsor website | http://www.kcl.ac.uk |
| Contact name | Prof Gabriel Panayi |
| Contact details | Department of Rheumatology
Guy's Hospital
London
United Kingdom
SE1 9RT |
| Contact email | gabriel.panayi@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN22288225 |
| Date last extracted from ISRCTN register | 17/04/2008 |
