Human stress protein (immunoglobulin Binding Protein [BiP]) for the treatment of rheumatoid arthritis

ISRCTN	ISRCTN22288225
DOI	https://doi.org/10.1186/ISRCTN22288225
Protocol serial number	BiP-01
Sponsor	King's College London Enterprises (UK)
Funder	Immune Regulation Ltd (UK)

Submission date: 25/07/2007
Registration date: 04/09/2007
Last edited: 09/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gabriel Panayi
Scientific

Department of Rheumatology
Guy's Hospital
London
SE1 9RT
United Kingdom

Email	gabriel.panayi@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised placebo-controlled single escalating dose trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Human stress protein (immunoglobulin Binding Protein [BiP]) for the treatment of rheumatoid arthritis: a randomised, placebo-controlled, single escalating dose trial
Study objectives	BiP will safely suppress inflammatory joint synovitis in patients with rheumatoid arthritis.
Ethics approval(s)	Guy's and St Thomas's NHS Trust Hospital Ethics Board, 01/04/2008, ref: 07/H0802/114
Health condition(s) or problem(s) studied	Rheumatoid arthritis
Intervention	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 who 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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Human stress protein (immunoglobulin Binding Protein [BiP])
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	1. Clinical efficacy as measured by the American 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.
Completion date	01/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	32
Key inclusion criteria	1. Active rheumatoid arthritis (RA) 2. Females aged 25 to 75 years
Key exclusion criteria	1. Intercurrent serious disease 2. Malignancy 3. Pregnant/lactating
Date of first enrolment	01/09/2012
Date of final enrolment	01/08/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Guy's Hospital

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/08/2016: Publication reference added.
15/08/2014: the overall trial end date was changed from 01/09/2011 to 01/12/2014.
11/02/2009: the following changes were made to the trial record:
1. The overall trial start date was changed from 01/06/2008 to 01/09/2009.
2. The overall trial end date was changed from 01/06/2011 to 01/09/2011.