Last updated: 11/03/2018 13:21:12

HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II

GSK study ID
112657
See study documents
Clinicaltrials.gov ID
NCT00291928
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A double-blind, randomized, placebo controlled, dose escalation, multi-centerphase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20antibody, in patients with active rheumatoid arthritis who have previously failedone or more disease modifying anti-rheumatic drugs
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of participants with Adverse events (AE) and serious adverse events (SAE) in Part A of study

Timeframe: Up to Week 66

Number of participants with American College of Rheumatology (ACR)20 at week 24 in Part B of study

Timeframe: Week 24 of part B

Secondary outcomes:

Number of participants with ACR20, ACR50, and ACR70 at weeks 12, 16, 20 and 24 in Part A of study

Timeframe: Week 12, 16, 20 and 24 in Part A of study

Percent ACRn at Weeks 12, 16, 20 and 24 in part A of study

Timeframe: Weeks 12, 16, 20 and 24 in part A of study

Change from Baseline in Disease activity score (DAS) at weeks 12, 16, 20 and 24 in Part A of study

Timeframe: Weeks 12, 16, 20 and 24 in Part A of study

Percent change from Baseline in CD19+ cells and CD20+ cells at weeks 12, 16, 20 and 24 in Part A of study

Timeframe: Baseline (Day 0), Weeks 12, 16, 20 and 24 in Part A of study

Number of participants with ACR20 at weeks 12, 16, 20, 36, and 48 in Part B of study

Timeframe: Week 12, 16, 20, 36, and 48 in Part B of study

Number of participants with ACR50 and ACR70 at Weeks 12, 16, 20, 24, 36, and 48 in Part B of study

Timeframe: Weeks 12, 16, 20, 24, 36, and 48 in Part B of study

Percent ACRn at weeks 12, 16, 20, 24, 36, and 48 in Part B of study

Timeframe: Weeks 12, 16, 20, 24, 36, and 48 in Part B of study

Change from Baseline in DAS at Weeks 12, 16, 20, 24, 36, and 48 in Part B of study

Timeframe: Baseline (Day 0) and at Weeks 12, 16, 20, 24, 36, and 48 in Part B of study

Percent change from baseline in CD19+ cells at weeks 12, 16, 20, 24, 36, and 48 in Part B of study

Timeframe: Baseline (Day 0), Weeks 12, 16, 20, 24, 36, and 48 in Part B of study

Percent change from Baseline in CD20+ cells at 12, 16, 20 and 24 in Part B of study

Timeframe: Baseline (Day 0), Weeks 12, 16, 20 and 24 in Part B of study

Percent change from Baseline in Rheumatoid factor (RF) at Weeks 24, 36, and 48 in Part B of study

Timeframe: Baseline (Day 0), Weeks 24, 36, and 48 in Part B of study

Minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax) of ofatumumab in Part A and Part B of study

Timeframe: Pre-dose (0.0), at end of infusion, and at 10 minutes, 1 hour and 2 hours after infusion on Day 0 and Day 14 in Part A and Part B of study

Number of participants with any AEs in Part B of study

Timeframe: Every 12 weeks (±2w) after end of treatment (Week 24) until B-cells had returned to Baseline in Part B of study

Number of participants with Human Anti Human Antibodies (HAHA) against Ofatumumab at Week 24 of part A of study

Timeframe: Week 24

Number of participants with HAHA against ofatumumab at Week 24 and 48 in Part B of study

Timeframe: Week 24 and 48 in Part B of study

Percent change in Biochemistry parameters in Part A of study

Timeframe: Up to Week 24 in Part A of study

Percent change in Biochemistry parameters in B of study

Timeframe: Baseline (Visit 1), Week 2, 4, 8, 12, 16, 20 and 24 in B of study

Percent change in Hematology parameters in Part A of study

Timeframe: Baseline (Visit 1), Week 2, 4, 8, 12, 16, 20 and 24 in part A of study

Percent change in Hematology parameters in B of study

Timeframe: Baseline (Visit 1) Week 2, 4, 8, 12, 16, 20 and 24 in Part B of study

Percent change from Baseline in T-cells (CD3+, CD3+CD4+, and CD3+CD8+ cells) and Natural killer cells (CD3-CD16+CD56+ cells) at Week 4 in Part A and B of study

Timeframe: Baseline (Day 0) and Week 4

Percent change from Baseline in Complement (CH50) at Week 4 in Part A and B of study

Timeframe: Baseline (Day 0) and Week 4 in Part A and B of study

Number of participants with Abnormalities of Potential Clinical Importance in body weight and electrocardiogram (ECG) in Part A of the study

Timeframe: Up to Week 24 in Part A

Number of participants with Abnormalities of Potential Clinical Importance in ECG in Part B of the study

Timeframe: Up to Week 24 in Part B of study

Interventions:
  • Drug: Part A
  • Drug: Part B
    • Enrollment:
    264
    Primary completion date:
    2007-26-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Arthritis, Rheumatoid
    Product
    ofatumumab
    Collaborators
    Not applicable
    Study date(s)
    February 2005 to July 2010
    Type
    Interventional
    Phase
    1/2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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).
    • Use of DMARDs other than methotrexate.
    • Current or previous (within four weeks of screening) participation in any other clinical trial.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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.
    Exclusion criteria:
    • 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-26-09
    Actual study completion date
    2010-21-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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