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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22288225

Enrollment

Registered

2007-09-04

Start date

2012-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Arthropathies

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 who have

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Intercurrent serious disease 2. Malignancy 3. Pregnant/lactating

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026