Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients

NCT ID: NCT00686868

Last Updated: 2017-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-13
• Study Completion Date: 2011-05-02

Brief Summary

This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

30mg

active

Group Type: EXPERIMENTAL

ofatumumab

Intervention Type: DRUG

fully human anti-CD20 monoclonal antibody

3mg

active

Group Type: EXPERIMENTAL

ofatumumab

Intervention Type: DRUG

fully human anti-CD20 monoclonal antibody

0.3mg

active

Group Type: EXPERIMENTAL

ofatumumab

Intervention Type: DRUG

fully human anti-CD20 monoclonal antibody

placebo

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo

60mg

60mg

Group Type: EXPERIMENTAL

ofatumumab

Intervention Type: DRUG

fully human anti-CD20 monoclonal antibody

100mg

100mg

Group Type: EXPERIMENTAL

ofatumumab

Intervention Type: DRUG

fully human anti-CD20 monoclonal antibody

Interventions

placebo

placebo

Intervention Type: OTHER

ofatumumab

fully human anti-CD20 monoclonal antibody

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female aged ≥ 18 years
• A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months prior to screening
• Subjects must be treated with MTX, 7.5-25 mg/week, for at least 12 weeks prior to Visit 2, with the last 4 weeks prior to Day 2 at a stable dosage
• Patient must be willing to receive folic acid ≥5mg/wk 4 weeks prior to baseline administered according to locally accepted practice
• Body mass index (BMI) < 35kg/m2 (inclusive)
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria

• Subjects with a history of a rheumatic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome)
• Previous exposure to biologic cell depleting anti-rheumatic therapies, including investigational compounds (e.g. anti-CD11a, anti-CD19, anti-CD20, anti-CD22, anti-BLyS/BAFF, anti-CD3, anti-CD4, anti-CD5, anti-CD52)
• Exposure to etanercept < 4 weeks, infliximab or adalimumab < 8 weeks, or abatacept or anakinra < 12 weeks prior to visit 2
• Received any of the following treatments within 4 weeks prior to Visit 2:
• Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)
• Glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day
• Intra-articular, i.m. or IV corticosteroids
• Live/attenuated vaccinations
• Cyclosporine
• Azathioprine
• Penicillamine
• Sulfasalazine
• Bucillamine
• Hydroxychloroquine
• Chloroquine
• Exposure to leflunomide within 12 weeks prior to visit 2 unless the subject has completed peroral cholestyramine treatment
• Exposure to gold therapy ≤ 12 weeks prior to Visit 2
• Exposure to IV immunogammaglobulins ≤ 24 weeks prior to Visit 2
• Past or current malignant melanoma
• Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, renal infection, chest infection with bronchiectasis, tuberculosis and active hepatitis B and C
• History of significant cerebrovascular disease
• Positive plasma / white cell JC Virus (JCV) PCR (either compartment)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Miramar, Florida, United States

GSK Investigational Site

Randwick, New South Wales, Australia

GSK Investigational Site

Adelaide, South Australia, Australia

GSK Investigational Site

Heidelberg, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Échirolles, , France

GSK Investigational Site

Verona, Veneto, Italy

GSK Investigational Site

Christchurch, , New Zealand

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Ryazan, , Russia

GSK Investigational Site

Smolensk, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Madrid, , Spain

Countries

United States; Australia; Belgium; France; Italy; New Zealand; Poland; Russia; Spain

References

Kurrasch R, Brown JC, Chu M, Craigen J, Overend P, Patel B, Wolfe S, Chang DJ. Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics. J Rheumatol. 2013 Jul;40(7):1089-96. doi: 10.3899/jrheum.121118. Epub 2013 Jun 1.

Reference Type: DERIVED

PMID: 23729801 (View on PubMed)

Other Identifiers

OFA110867

Identifier Type: -

Identifier Source: org_study_id