NCT00291928

Brief Summary

The purpose of this trial is primarily to investigate the safety profile of HuMax-CD20 in patients with active RA. Furthermore, the trial is designed to identify the dose levels to be used in future trials (based on evaluations of safety, pharmacokinetics and ACR and DAS responses).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

2.6 years

First QC Date

February 14, 2006

Last Update Submit

November 8, 2012

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (2)

  • To evaluate the safety of HuMax-CD20 in patients with active rheumatoid arthritis

    24 weeks

  • To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis using the American College of Rheumatology (ACR) Response Assessment and Disease Activity Score (DAS) at 12 to 24 weeks after initiation of treatment

    24 weeks

Secondary Outcomes (5)

  • To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis by measuring the degree and duration of B-cell depletion

    24 weeks

  • To determine the pharmacokinetic profile of HuMax-CD20 in patients with active rheumatoid arthritis

    24 weeks

  • To determine host immune response, Human Anti Human Antibodies (HAHA), against HuMax-CD20

    24 weeks

  • To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis using the American College of Rheumatology (ACR) Response Assessment and Disease Activity Score (DAS) at 36 & 48 weeks after initiation of treatment

    48 weeks

  • To evaluate if Fc-receptor polymorphism influences the safety and efficacy of HuMax-CD20 in patients with active rheumatoid arthritis

    24 weeks

Study Arms (2)

Dose ranging

PLACEBO COMPARATOR

A double-blind, placebo controlled, dose escalation part randomized within each of 3 sequential cohorts (Part A),

Drug: Part A

Parallel Arm RCT

PLACEBO COMPARATOR

a parallel group part with randomization into one of 4 treatment arms (Part B).

Drug: Part B

Interventions

Part ADRUG

Part A Cohort 1: HuMax-CD20 300 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 2: HuMax-CD20 700 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 3: HuMax-CD20 1000 mg at Days 0 and 14 or Placebo at Days 0 and 14

Dose ranging
Part BDRUG

Part B Group 1: HuMax-CD20 300 mg at Days 0 and 14 Group 2: HuMax-CD20 700 mg at Days 0 and 14 Group 3: HuMax-CD20 1000 mg at Days 0 and 14 Group 4: Placebo at Days 0 and 14

Parallel Arm RCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Active rheumatoid arthritis according to the American College of Rheumatology of at least six months duration with six or more swollen and six or more tender joints (of 28 joints) and Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/h and/or C-Reactive Protein (CRP) ≥ 10 mg/L (1 mg/dL).
  • Treatment failure to one or more DMARDs.
  • Treatment with methotrexate (7.5-25 mg/wk) for at least 12 weeks and at a stable dose for at least 4 weeks prior to planned start of trial treatment.

You may not qualify if:

  • Use of DMARDs other than methotrexate.
  • Current or previous (within four weeks of screening) participation in any other clinical trial.
  • Previous exposure to other biological products within 4 weeks prior to planned start of trial treatment, and/or exposure to anti-CD20 antibodies within two years before screening for this trial.
  • Any use of cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents within five years before screening for this trial.
  • Active autoimmune disease (other than RA and RA-associated secondary diseases) requiring immunosuppressive therapy.
  • Past or current malignancy, except for resected cervical carcinoma Stage 1B or less, non-invasive basal cell and squamous cell skin carcinoma, malignant melanoma with a complete response of a duration of \> 10 years, or other cancer diagnoses with a complete response of a duration of \> 5 years.
  • Chronic or current infectious disease including known or suspected positive serology for HIV, hepatitis B, or hepatitis C.
  • Clinically significant cardiac disease, or history of significant cerebrovascular disease.
  • Significant concurrent, uncontrolled medical condition including, but not limited to: renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
  • Breast feeding women, women with a positive pregnancy test at screening, or women of childbearing potential not willing to use adequate contraception during the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Struemper H, Sale M, Patel BR, Ostergaard M, Osterborg A, Wierda WG, Hagenbeek A, Coiffier B, Jewell RC. Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis. J Clin Pharmacol. 2014 Jul;54(7):818-27. doi: 10.1002/jcph.268. Epub 2014 Jan 28.

    PMID: 24443277DERIVED

  • Ostergaard M, Baslund B, Rigby W, Rojkovich B, Jorgensen C, Dawes PT, Wiell C, Wallace DJ, Tamer SC, Kastberg H, Petersen J, Sierakowski S. Ofatumumab, a human anti-CD20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomized, double-blind, placebo-controlled, phase I/II study. Arthritis Rheum. 2010 Aug;62(8):2227-38. doi: 10.1002/art.27524.

    PMID: 20506254DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Medicare Part B

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MedicareMedical AssistancePublic AssistanceFinancing, GovernmentFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsInsurance, HealthInsuranceLegislation as TopicSocial Control, Formal

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 15, 2006

Study Start

February 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

November 12, 2012

Record last verified: 2012-11