A phase 1 randomised double blind, placebo-controlled, single dose, dose escalation study of KB002, a chimeric monoclonal antibody which binds to granulocyte macrophage-colony stimulating factor (GM-CSF), in patients with rheumatoid arthritis

A phase 1 randomised double blind, placebo-controlled, single dose, dose escalation study of the safety and tolerability profile of KB002, a chimeric monoclonal antibody which binds to granulocyte macrophage-colony stimulating factor (GM-CSF), in patients with rheumatoid arthritis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000248561

Enrollment

Registered

2006-06-20

Start date

2006-01-07

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of the study is to investigate the safety and the pharmacokinetics of KB002 in patients with rheumatoid arthritis. Patients will be randomly assigned 3:1 to KB002 or placebo. The study is double-blinded, with only the pharmacist unblinded. The investigator, study coordinator, patient, clinical research orgination (CRO) and sponsor are blinded to the treatment assignment.

Interventions

A single dose of KB002 administered intravenously over one hour to patients with rheumatiod arthritis.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Active rheumatoid arthritisCurrently receiving treatment with methotrexateStable doses of disease modifying anti-rheumatic drugs (DMARDs) for at least 8 weeksSwollen joint count of at least 6 (using 66 joint count)Tender joint count of at least 6 (using 68 joint count)Two out of three of the following:Erythrocyte sedimentation rate (ESR) greater than or equal to 20 mm/hrC-reactive protein (CRP) greater than or equal to 15 mg/dLEarly morning stiffness of greater than or equal to 45 minutes.

Exclusion criteria

Concurrent treatment with approved or investigational biological rheumatoid arthritis therapiesWhite blood cell (WBC) < 3.5 x 10^9/LAny major surgical operation or infrction within the last 8 weeks History of solid or haematological malignancy within the past 10 yearsFemales who are pregnant or breastfeedingMales or females unable to practice effective methods of birth control for 3 months after the infusion of study drugCurrent or past history of severe cardiac diseaseCurrent respiratory disease or a past history of chronic respiratory diseasePartial pressure of oxygen in arterial blood (PaO2) < 95% on room airCurrent smokers or a greater than or equal to 10 pack year history for ex-smokersImmune deficiency, chronic infections or chronic imflammatory conditiond other than rheumatoid arthritisDemylinating neurological disordersFelty's syndrome or myasthenia gravisAny other illness Current or past treatmant with granulocyte macrophage-colony stimulating factor (GM-CSF) or granulocyte-colony stimulating factor (G-CSF)Previous treatment with an investigational agent within the last 90 daysVaccination within the last 30 days.

Outcome results