Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403

NCT00655824 | Terminated Phase 2 Results

• 2 other identifiers: 111752GEN413
• Study Type: interventional
• Target: 124
• Locations: 5 countries
• Sites: 10

Brief Summary

A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9 treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo in Trial Hx-CD20-403.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Time to Treatment Withdrawal

  Time to treatment withdrawal was defined as the time from the first infusion of ofatumumab until the date of treatment withdrawal. The sponsor discontinued the intravenous route of administration development program for rheumatoid arthritis (RA), and this study was terminated early; hence, this primary endpoint was not evaluated.

  From Baseline up to 144 weeks

Secondary Outcomes (30)

• Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour)

  Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

• Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP)

  Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

• Time to Re-treatment in Each Treatment Course

  Week 16 to Week 104 of each treatment course (up to 125 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

• Ofatumumab Serum Concentration

  Before infusion and at the end of infusion for each Treatment Course (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next TC; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial vi

• Number of Participants Achieving American College of Rheumatology (ACR)20

  Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.

Study Arms (1)

Ofatumumab

EXPERIMENTAL

1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl

Drug: ofatumumab

Interventions

ofatumumab DRUG

1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl

Ofatumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously received ofatumumab or placebo in Trial Hx-CD20-403.
• Patients on methotrexate therapy (7.5 - 25 mg/week, p.o., i.m., and/or s.c.).
• Oral corticosteroids therapy (≤ 10 mg/day prednisolone or equivalent).
• Active disease at the time of screening as defined by:
• swollen joints (of 28 joints assessed) and ≥ 3 tender joints (of 28 joints assessed), DAS28≥3.2 (based on ESR)

You may not qualify if:

• Use of DMARDs other than methotrexate or exposure to other cell depleting therapy, including investigational compounds \< 6 months prior to Visit 2 A.
• Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening).
• Breast feeding women or women with a positive pregnancy test at Visit 1 (screening).
• Received anti-cancer therapy, corticosteroids (intra-articular, i.m., or i.v.), or live/attenuated vaccinations, or exposure to cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents \< 5 years prior to screening.
• Past or current malignancy, except for 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 ongoing active infectious disease requiring systemic treatment.
• Clinically significant cardiac disease, or history of significant cerebrovascular disease.
• Significant concurrent, uncontrolled medical conditions, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease
• Known or suspected HIV positive, positive serology for hepatitis B (HB), positive test for Hepatitis C, or positive plasma or white cell JC virus (JCV) PCR (either compartment).
• A circulating IgG level \<lower limit of normal.
• Known hypersensitivity to components of the investigational medicinal product.
• Patients known or suspected of not being able to comply with a study protocol.
• Women of child bearing potential not will to use adequate contraception during study

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Los Angeles, California, 90095, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33334, United States

Location

GSK Investigational Site

New York, New York, 10003, United States

Location

GSK Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

GSK Investigational Site

Copenhagen, 2100, Denmark

Location

GSK Investigational Site

Glostrup Municipality, 2600, Denmark

Location

GSK Investigational Site

Hellerup, 2900, Denmark

Location

GSK Investigational Site

Szombathely, 9700, Hungary

Location

GSK Investigational Site

Warsaw, 02-256, Poland

Location

GSK Investigational Site

Ipswich, IP4 5PD, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Development of the IV route of ofatumumab (OFA) administration in RA will no longer be pursued. This study was prematurely terminated; OFA treatment was discontinued. Participants could complete only \<=7 treatment courses and a follow-up evaluation.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: January 1, 2008
• Primary Completion: May 25, 2011
• Study Completion: March 19, 2013
• Last Updated: December 5, 2017
• Results First Posted: April 18, 2012

Record last verified: 2017-10

Locations

US (4); DK (3); HU (1); GB (1); PL (1)