A Phase 2 interventional study of Part A and Part B in Arthritis, Rheumatoid, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-12.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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).
This trial consists of a double-blind, placebo controlled, dose escalation part with randomization to trial treatment within each of three sequential cohorts (Part A), and a parallel group part with randomization into one of four treatment arms (Part B). Patients in Parts A and B will receive two infusions of either HuMax-CD20 (300 mg, 700 mg, or 1000 mg) or placebo and will be followed for safety, efficacy, and pharmacokinetic measurements for 24 weeks. Hereafter patients will be followed every 12 weeks until B-cells (CD19+ cells) have returned to baseline levels. For patients in Part B, the follow-up visits at 36 and 48 weeks after initial trial treatment (Follow-up Visits 1 and 2) will include additional measurements of safety and efficacy.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 201 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A double-blind, placebo controlled, dose escalation part randomized within each of 3 sequential cohorts (Part A),
Drug: Part A
a parallel group part with randomization into one of 4 treatment arms (Part B).
Drug: Part B
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
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
To evaluate the safety of HuMax-CD20 in patients with active rheumatoid arthritis
Time frame: 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
Time frame: 24 weeks
To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis by measuring the degree and duration of B-cell depletion
Time frame: 24 weeks
To determine the pharmacokinetic profile of HuMax-CD20 in patients with active rheumatoid arthritis
Time frame: 24 weeks
To determine host immune response, Human Anti Human Antibodies (HAHA), against HuMax-CD20
Time frame: 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
Time frame: 48 weeks
To evaluate if Fc-receptor polymorphism influences the safety and efficacy of HuMax-CD20 in patients with active rheumatoid arthritis
Time frame: 24 weeks
No study locations are listed for this record.
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline