Long-term efficacy and safety of repeated ofatumumab treatment courses in RA patients who previously received ofatumumab or placebo in Trial Hx-CD20-403
Trial overview
Time to treatment withdrawal
Timeframe: From Baseline up to 144 weeks
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)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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.
Number of participants achieving ACR50
Timeframe: Baseline of each TCand 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.
Number of participants achieving ACR70
Timeframe: 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.
Number of participants with the indicated European League Against Rheumatism (EULAR) response
Timeframe: 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.
Number of participants in the indicated categories of the Health Assessment Questionnaire (HAQ)
Timeframe: 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.
Number of participants with the indicated Global Disease Assessment using the VAS
Timeframe: 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.
Number of participants with the indicated pain score
Timeframe: 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.
Number of participants with HAHA response
Timeframe: 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.
Whole blood transcriptional profiles
Timeframe: 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.
Percentage of cluster of differentiation (CD)19+, 4+, 3+, and 8+ B-cell subsets in the blood
Timeframe: 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.
CD19+, CD4+, CD3+, and CD8+ cell counts, measured in mm^3
Timeframe: 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.
Ratio of CD 4+/CD8+
Timeframe: 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.
Number of participants with rheumatoid factor (RA factor) >13 International Units per milliliter
Timeframe: 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.
Number of participants with Anti-cyclic citrullinated peptide antibody (CCP) >6.9 International Units per liter
Timeframe: 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.
Number of participants with B-Lymphocyte Stimulator (BLyS) >2.49 micrograms per liter
Timeframe: 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.
Number of participants with Interleukin 6 (IL-6) >11.9 picograms per milliliter
Timeframe: 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.
Assessment of sodium, potassium, chloride, bicarbonate, calcium, and uric acid
Timeframe: 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.
Assessment of total protein (TP) and albumin
Timeframe: 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.
Assessment of total bilirubin (TB) and creatinine
Timeframe: 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.
Assessment of alanine aminotranferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), and gamma glutamyl-transferase (GGT)
Timeframe: 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.
Assessment of blood urea nitrogen (BUN)
Timeframe: 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.
Assessment of systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timeframe: BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk
Assessment of heart rate (HR)
Timeframe: BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk
Assessment of body temperature (BT)
Timeframe: BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk
Assessment of lactic dehydrogenase (LDH) and creatine phosphokinase (CPK)
Timeframe: 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.
Number of participants with normal and abnormal electrocardiogram readings
Timeframe: 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.
Participation criteria
- 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.).
- 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).
- 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: ≥ 3 swollen joints (of 28 joints assessed) and ≥ 3 tender joints (of 28 joints assessed), DAS28≥3.2 (based on ESR)
- 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
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.