Condition category
Musculoskeletal Diseases
Date applied
25/07/2007
Date assigned
04/09/2007
Last edited
09/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gabriel Panayi

ORCID ID

Contact details

Department of Rheumatology
Guy's Hospital
London
SE1 9RT
United Kingdom
-
gabriel.panayi@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BiP-01

Study information

Scientific title

Human stress protein (immunoglobulin Binding Protein [BiP]) for the treatment of rheumatoid arthritis: a randomised, placebo-controlled, single escalating dose trial

Acronym

Study hypothesis

BiP will safely suppress inflammatory joint synovitis in patients with rheumatoid arthritis.

Ethics approval

Guy's and St Thomas's NHS Trust Hospital Ethics Board, 01/04/2008, ref: 07/H0802/114

Study design

Randomised placebo-controlled single escalating dose trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Human stress protein (immunoglobulin Binding Protein [BiP])

Primary outcome measures

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 measures

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.

Overall trial start date

01/09/2009

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Active rheumatoid arthritis (RA)
2. Females aged 25 to 75 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

32

Participant exclusion criteria

1. Intercurrent serious disease
2. Malignancy
3. Pregnant/lactating

Recruitment start date

01/09/2012

Recruitment end date

01/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's Hospital
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London Enterprises (UK)

Sponsor details

Capital House
Guy's Hospital
London
SE1 9RT
United Kingdom
+44 (0)20 7188 5880
gabriel.panayi@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Industry

Funder name

Immune Regulation Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27498355

Publication citations

Additional files

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.