Back to resultsLong-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris
Primary Purpose
Pemphigus
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ofatumumab
Acetaminophen/paracetamol
Antihistamine (cetirizine or equivalent)
Prednisone/Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Pemphigus focused on measuring Ofatumumab, Pemphigus Vulgaris, Long-Term Extension Study
Eligibility Criteria
Inclusion Criteria:
- Adult with clinically documented diagnosis of PV.
- Completed Study OPV116910 through Week 60 with one of the following outcomes:
Did not achieve remission by Week 60 of OPV116910. Achieved remission on a steroid dose >10 milligrams/day. Achieved remission on minimal steroid therapy, but is experiencing a disease flare/relapse while participating in the first year (yr)of the OPV116910 Individualized Follow up Period (It is recommended subjects are transitioned to the extension study before the steroid dose is increased).
- A woman is eligible to enter the study if she:
Is of non-childbearing potential: documented as surgically sterile (bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion) or is postmenopausal without menses for >2 years. Women who are <2 years postmenopausal are required to have menopausal status confirmed by follicle-stimulating hormone (FSH) and estradiol levels at the baseline evaluation. If FSH and estradiol levels do not provide confirmation of menopause, subject will be considered to be of childbearing potential.
Is of childbearing potential, with a negative pregnancy test at baseline, and agrees to the consistent and correct use of acceptable methods of contraception (Highly-Effective Methods for Avoiding Pregnancy) during heterosexual intercourse, beginning when the subject provides informed consent and lasting until 12 months after last dose of ofatumumab SC.
Exclusion Criteria:
- Past or current history of hypersensitivity to components of the investigational product or medically-significant adverse effects (including allergic reactions) from cetirizine (or antihistamine equivalent) or paracetamol/acetaminophen.
- Prior treatment with any of the following within the specified periods:
Medication and Other Treatment Restrictions Prior to OPV117059 Baseline Any time- Ofatumumab (Intravenous), total body irradiation, bone marrow transplantation, anti CD4; 6 weeks -Live vaccine 8 weeks- Immunosuppressive or immunomodulatory agents, including: azathioprine, cyclosporine, dapsone, mycophenolate, methotrexate, tacrolimus 6 months- Cyclophosphamide, cladribine, plasmapheresis, immunoabsorption, or immunoglobulin therapy, alemtuzumab, mitoxantrone 18 months -Rituximab or other anti CD20 treatments
- Confirmed PML or neurological findings potentially consistent with PML.
- Evidence or history of clinically significant infection or medical condition including:
Chronic or ongoing active infectious disease requiring long term systemic treatment, including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, or active hepatitis C.
Positive test for hepatitis B surface antigen (HbsAg). For HbsAg negative, but hepatitis B core antibody positive (anti-HBc) (regardless of hepatitis B surface antibody [HbsAb] status), a hepatitis B virus deoxyribonucleic acid (HBV DNA) test will be performed and the subject will be excluded if results are positive. Consult with a physician experienced in the care and management of subjects with hepatitis B to manage/treat subjects who are anti HBc positive. Subjects who are anti-HBc positive and HBV DNA negative will continue to be monitored throughout the study.
History of positive serology for human immunodeficiency virus. Previous serious opportunistic or atypical infections. Prior history, or suspicion, of tuberculosis. A radiograph of the chest taken within 3 months before the first administration of investigational product suggests no evidence indicating current active tuberculosis or previous tuberculosis.
- Past or current malignancy, except for: Cervical carcinoma Stage 1B or less; Noninvasive basal cell and squamous cell skin carcinoma; Cancer diagnoses with a duration of complete response (remission) >5 years.
- Clinical chemistry and/or hematology laboratory values of clinical concern, in the investigator's opinion.
For subjects transitioning directly from the OPV116910 study, review central chemistry and hematology laboratory reports from the Week 48 through Week 56 visits of OPV116910.
For subjects transitioning from the Individualized Follow-up Period of OPV116910, review central chemistry and hematology laboratory reports from the most recent OPV116910 Individualized Follow-up visit. If the date of that laboratory report is more than 12 weeks from the extension study Screening visit, then the laboratory assessments need to be repeated.
For subjects with neutropenia (absolute neutrophil count <1 Giga units per liter, the neutropenia must resolve before the first dose of ofatumumab, which should occur within 4 weeks of the screening assessments.
- Electrocardiogram (ECG) showing a clinically significant abnormality or showing a Corrected QT Interval (QTc) interval >=450 millisecond (msec) (>=480 msec for subjects with bundle branch block) (ECG will be obtained during Week 60 visit of OPV116910; Repeat ECG if more than 12 weeks have elapsed).
- Significant concurrent, uncontrolled medical condition that could affect the subject's safety, impair the subject's reliable participation in the study, impair the evaluation of endpoints, or necessitate the use of medication not allowed by the protocol.
- In the Investigator's opinion, there is a reason why the subject would not be eligible for this study (eg, the subject is unable to comply with the visit schedule).
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ofatumumab
Arm Description
t the Baseline (Bln) and wk 4 visits, Subjects will receive 40mg ofatumumab sc (Oft) (as two 20mg sc inj) and as 1 Oft 20mg sc inj every 4 wks from wk 8 through wk 56. Subjects will return to clinic 4 wks after the last dose for a follow-up (f/u) visit (wk 60). Antihistamine 10 mg and Acetaminophen/paracetamol (A/P) 1 grams(g) will be given 1-2 hours(h) before and 4 h after each dose of Oft. A/P 1 g will be supplied for self administration if needed. Prednisone/Prednisolone dose will continue to be tapered during core study period (CSP) by 1 dose level every 2 wks to <= 10 mg/day from Bln through wk 60. Upon completion of the CSP, subjects will enter Individualized f/u Period, where subjects will monitored every 12 wks for a minimum of 1 yr and for up to 2 yr, until CD19+ B-LC or IgG recover to lower limit of normal (LLN) or to the subject's Bln value from Study OPV116910 (if <LLN) or if study withdrawal criteria are met or for a maximum of 2 yr after the last dose of Oft.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled.
Number of Participants With Severe Adverse Events
Severity is a category utilized for rating the intensity of an adverse event. Participants with severe AEs were to be summarized. No serious adverse events (SAEs) were reported for the one participant enrolled.
Number of Participants With Adverse Events Related to Ofatumumab SC
Participants with AEs related to ofatumumab were to be summarized. No adverse events related to ofatumumab were reported for the one participant enrolled.
Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were to be categorized as SAE. AEs of special interest included any opportunistic infections, serious post injection systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus infection or reactivation, severe mucocutaneous reactions (e.g., toxic epidermal necrolysis and stevens-johnson syndrome), cytopenias and cardiovascular events. Participants with SAEs and AESI were to be summarized. No serious adverse events (SAEs) or adverse events of special interest (AESI) reported.
Number of Participants Withdrawn Due to Treatment-related AEs
Participants withdrawn due to treatment related AEs were to be summarized. One participant was enrolled into the study and was withdrawn early due to study termination. The participant was not withdrawn due to treatment-related AEs.
Number of Participants With Infections
All infections were planned to be monitored closely throughout the study and participants with infections were to be summarized. No cases of infection were reported for the one participant.
Number of Participants With Post-injection Systemic Reactions
All serious post-injection systemic reactions were planned to be monitored closely throughout the study and number of participants with post-injection systemic reactions was to be summarized. No cases of post-injection systemic reactions were reported for the one participant.
Number of Participants With Injection Site Reactions
Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
SBP and DBP were to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained after at least 5 minutes of rest. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Heart Rate at the Indicated Time Points
Heart rate was to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained in the sitting position and at the time of the blood pressure measurement. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed
Change From Baseline in Body Temperature at the Indicated Time Points
Body temperature was planned to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to termination of study, analysis of this information was not performed.
Number of Participants With Vital Signs of Clinical Concern
Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant.
Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities
12-lead ECG was planned to be taken on Baseline (Week 0) and at Follow-up visit (Week 60). No clinically significant ECG abnormalities were noted for the one participant.
Change From Baseline in Hemoglobin at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Hematocrit at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in White Blood Cell (WBC) Count, Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte, Platelet Count, Bands, Cluster of Differentiation (CD)19+ B-lymphocyte Counts, CD3, CD4 and CD8 at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in CD4: CD8 Ratio at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Red Blood Cell (RBC) Count and Nucleated RBCs at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Total Protein and Albumin at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Sodium, Potassium, Chloride, Calcium, Glucose, Bicarbonate and Blood Urea Nitrogen at the Indicated Time Points
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Creatinine Clearance (Calculated) at the Indicated Time Points
Blood samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Number of Participants With Change in Urinalysis Results
Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of appearance, protein, glucose, leukocyte esterase, ketones, hemoglobin, microalbumin, creatinine, microalbumin:creatinine ratio and microscopy which included RBC/high powered field, WBC/ hight powered field, epithelial cells, trichomonas, bacteria, yeast, crystals, ammonium urates, mucous threads, amorphous sediment and casts. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Urine Power of Hydrogen (pH) at the Indicated Time Points
Urine samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of pH. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.
Change From Baseline in Specific Gravity of Urine
Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of urine specific gravity. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.
Number of Participants With Laboratory Results of Potential Clinical Concern
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of clinical chemistry parameters; and at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of hematology parameters. No laboratory values of potential clinical concern were identified for this one participant.
Change From Baseline in Immunoglobulin (Ig) A, IgM, and IgG Levels
Blood samples for IgA, IgM, and IgG analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Secondary Outcome Measures
Time to Sustained Remission on Minimal Steroid Therapy
Time to sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >= 8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.
Duration of Remission on Minimal Steroid Therapy
Duration of remission on minimal steroid therapy is the total time (sum) of all periods of remission while on minimal steroid therapy (oral prednisone/prednisolone dose <=10 mg/day) up to Week 60. Due to the termination of this study, analysis of this information was not performed.
Number of Participants Achieving Sustained Remission on Minimal Steroid Therapy by Week 60
Sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.
Time to Remission Off Steroid Therapy by Week 60
Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.
Number of Participants Achieving Remission While Off Steroid Therapy by Week 60
Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.
Number of Participants Achieving Remission on Minimal Steroid Therapy
Remission is defined as absence of new or non-healing (established) lesions for >=8 weeks and minimal steroid therapy is defined as an oral prednisone/prednisolone dose of <=10 mg/day. Due to the termination of this study, analysis of this information was not performed.
Time to Remission on Minimal Steroid Therapy
Time to remission on minimal steroid therapy is the time from Baseline to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks by Week 60. Due to the termination of this study, analysis of this information was not performed.
Duration of Remission After Completing the Ofatumumab SC Treatment Course
Duration of remission after completing the ofatumumab SC treatment course was to be assessed during the individualized Follow-up period for participants who were in remission on minimal steroid therapy by Week 60. Due to the termination of this study, analysis of this information was not performed.
Time to Initial Flare/Relapse by Week 60
Time to initial flare/relapse is time from Baseline to the time of appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. The appearance of 1 or 2 new lesions was not to be considered a flare/relapse. Due to the termination of this study, analysis of this information was not performed.
Number of Participants Who do Not Flare/Relapse
It was planned to assess participants with out an appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or an extension (worsening) of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.
Number of Participants Who do Not Flare/Relapse on Minimal Steroid Therapy
It was planned to assess as participants who achieved remission on minimal steroid therapy and did not subsequently have a flare/relapse of disease by Week 60. Due to the termination of this study, analysis of this information was not performed.
Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course
It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.
Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course During the Individualized Follow-up Period
It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.
Number of Days Minimal Steroid Therapy is Maintained by Week 60
Minimal steroid therapy is an oral prednisone/prednisolone dose of <= 10 mg/day. Due to the termination of this study, analysis of this information was not performed.
Number of Days a Participant is Off Steroid Therapy by Week 60
Number of days, a participant did not require steroid therapy was observed and summarized. Due to the termination of this study, analysis of this information was not performed.
Cumulative Dose of Corticosteroids
Cumulative dose of corticosteroids was calculated to evaluate steroid exposure and reductions in steroid dose while maintaining disease control. Due to the termination of this study, analysis of this information was not performed.
Number of Participants With Positive Human Anti-human Antibody (HAHA) Immune Response
Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.
Titer of Human Anti-human Antibody
Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02613910
Brief Title
Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris
Official Title
OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Novartis has acquired the rights to ofatumumab and terminated the OPV116910 and OPV117059 studies. This decision is not linked to any safety consideration.
Study Start Date
December 23, 2015 (Actual)
Primary Completion Date
March 23, 2016 (Actual)
Study Completion Date
March 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed as a multi-country, multicenter, open label extension to Phase III trial OPV116910. The primary objective is to provide continued treatment with ofatumumab subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain further long term safety and tolerability information in subjects with pemphigus vulgaris receiving ofatumumab SC every 4 weeks (wk).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pemphigus
Keywords
Ofatumumab, Pemphigus Vulgaris, Long-Term Extension Study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ofatumumab
Arm Type
Experimental
Arm Description
t the Baseline (Bln) and wk 4 visits, Subjects will receive 40mg ofatumumab sc (Oft) (as two 20mg sc inj) and as 1 Oft 20mg sc inj every 4 wks from wk 8 through wk 56. Subjects will return to clinic 4 wks after the last dose for a follow-up (f/u) visit (wk 60). Antihistamine 10 mg and Acetaminophen/paracetamol (A/P) 1 grams(g) will be given 1-2 hours(h) before and 4 h after each dose of Oft. A/P 1 g will be supplied for self administration if needed. Prednisone/Prednisolone dose will continue to be tapered during core study period (CSP) by 1 dose level every 2 wks to <= 10 mg/day from Bln through wk 60. Upon completion of the CSP, subjects will enter Individualized f/u Period, where subjects will monitored every 12 wks for a minimum of 1 yr and for up to 2 yr, until CD19+ B-LC or IgG recover to lower limit of normal (LLN) or to the subject's Bln value from Study OPV116910 (if <LLN) or if study withdrawal criteria are met or for a maximum of 2 yr after the last dose of Oft.
Intervention Type
Drug
Intervention Name(s)
Ofatumumab
Intervention Description
Ofatumumab (human monoclonal antibody) will be provided as a liquid concentrate in a prefilled glass syringe with staked needle, stopper, and plunger containing 0.4 millilitre (mL) (20 mg) drug product of 50 mg/mL concentration
Intervention Type
Drug
Intervention Name(s)
Acetaminophen/paracetamol
Intervention Description
Acetaminophen/paracetamol will be supplied by study centre as 1 gram tablet, caplet, capsule or liquid for oral administration
Intervention Type
Drug
Intervention Name(s)
Antihistamine (cetirizine or equivalent)
Intervention Description
Antihistamine (cetirizine or equivalent) will be supplied by study center as 10 mg tablet, caplet, capsule or liquid for oral administration
Intervention Type
Drug
Intervention Name(s)
Prednisone/Prednisolone
Intervention Description
Prednisone/Prednisolone will be supplied from the dose range 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 25, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180, 200, 220 and 240 mg for oral administration
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)
Description
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled.
Time Frame
Up to Week 60
Title
Number of Participants With Severe Adverse Events
Description
Severity is a category utilized for rating the intensity of an adverse event. Participants with severe AEs were to be summarized. No serious adverse events (SAEs) were reported for the one participant enrolled.
Time Frame
Up to Week 60
Title
Number of Participants With Adverse Events Related to Ofatumumab SC
Description
Participants with AEs related to ofatumumab were to be summarized. No adverse events related to ofatumumab were reported for the one participant enrolled.
Time Frame
Up to Week 60
Title
Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
Description
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were to be categorized as SAE. AEs of special interest included any opportunistic infections, serious post injection systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus infection or reactivation, severe mucocutaneous reactions (e.g., toxic epidermal necrolysis and stevens-johnson syndrome), cytopenias and cardiovascular events. Participants with SAEs and AESI were to be summarized. No serious adverse events (SAEs) or adverse events of special interest (AESI) reported.
Time Frame
Up to Week 156
Title
Number of Participants Withdrawn Due to Treatment-related AEs
Description
Participants withdrawn due to treatment related AEs were to be summarized. One participant was enrolled into the study and was withdrawn early due to study termination. The participant was not withdrawn due to treatment-related AEs.
Time Frame
Up to Week 60
Title
Number of Participants With Infections
Description
All infections were planned to be monitored closely throughout the study and participants with infections were to be summarized. No cases of infection were reported for the one participant.
Time Frame
Up to Week 60
Title
Number of Participants With Post-injection Systemic Reactions
Description
All serious post-injection systemic reactions were planned to be monitored closely throughout the study and number of participants with post-injection systemic reactions was to be summarized. No cases of post-injection systemic reactions were reported for the one participant.
Time Frame
Up to Week 60
Title
Number of Participants With Injection Site Reactions
Description
Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant.
Time Frame
Up to Week 60
Title
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
Description
SBP and DBP were to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained after at least 5 minutes of rest. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Baseline (Week 0) and up to Week 60
Title
Change From Baseline in Heart Rate at the Indicated Time Points
Description
Heart rate was to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained in the sitting position and at the time of the blood pressure measurement. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed
Time Frame
Baseline (Week 0) and up to Week 60
Title
Change From Baseline in Body Temperature at the Indicated Time Points
Description
Body temperature was planned to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to termination of study, analysis of this information was not performed.
Time Frame
Baseline (Week 0) and up to Week 60
Title
Number of Participants With Vital Signs of Clinical Concern
Description
Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant.
Time Frame
Up to Week 60
Title
Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities
Description
12-lead ECG was planned to be taken on Baseline (Week 0) and at Follow-up visit (Week 60). No clinically significant ECG abnormalities were noted for the one participant.
Time Frame
Up to Week 60
Title
Change From Baseline in Hemoglobin at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in Hematocrit at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in White Blood Cell (WBC) Count, Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte, Platelet Count, Bands, Cluster of Differentiation (CD)19+ B-lymphocyte Counts, CD3, CD4 and CD8 at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in CD4: CD8 Ratio at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in Red Blood Cell (RBC) Count and Nucleated RBCs at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in Total Protein and Albumin at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in Sodium, Potassium, Chloride, Calcium, Glucose, Bicarbonate and Blood Urea Nitrogen at the Indicated Time Points
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Change From Baseline in Creatinine Clearance (Calculated) at the Indicated Time Points
Description
Blood samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Number of Participants With Change in Urinalysis Results
Description
Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of appearance, protein, glucose, leukocyte esterase, ketones, hemoglobin, microalbumin, creatinine, microalbumin:creatinine ratio and microscopy which included RBC/high powered field, WBC/ hight powered field, epithelial cells, trichomonas, bacteria, yeast, crystals, ammonium urates, mucous threads, amorphous sediment and casts. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Change From Baseline in Urine Power of Hydrogen (pH) at the Indicated Time Points
Description
Urine samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of pH. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Change From Baseline in Specific Gravity of Urine
Description
Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of urine specific gravity. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Number of Participants With Laboratory Results of Potential Clinical Concern
Description
Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of clinical chemistry parameters; and at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of hematology parameters. No laboratory values of potential clinical concern were identified for this one participant.
Time Frame
Up to Week 156
Title
Change From Baseline in Immunoglobulin (Ig) A, IgM, and IgG Levels
Description
Blood samples for IgA, IgM, and IgG analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Secondary Outcome Measure Information:
Title
Time to Sustained Remission on Minimal Steroid Therapy
Description
Time to sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >= 8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Duration of Remission on Minimal Steroid Therapy
Description
Duration of remission on minimal steroid therapy is the total time (sum) of all periods of remission while on minimal steroid therapy (oral prednisone/prednisolone dose <=10 mg/day) up to Week 60. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Number of Participants Achieving Sustained Remission on Minimal Steroid Therapy by Week 60
Description
Sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Time to Remission Off Steroid Therapy by Week 60
Description
Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Number of Participants Achieving Remission While Off Steroid Therapy by Week 60
Description
Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Number of Participants Achieving Remission on Minimal Steroid Therapy
Description
Remission is defined as absence of new or non-healing (established) lesions for >=8 weeks and minimal steroid therapy is defined as an oral prednisone/prednisolone dose of <=10 mg/day. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Time to Remission on Minimal Steroid Therapy
Description
Time to remission on minimal steroid therapy is the time from Baseline to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks by Week 60. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Duration of Remission After Completing the Ofatumumab SC Treatment Course
Description
Duration of remission after completing the ofatumumab SC treatment course was to be assessed during the individualized Follow-up period for participants who were in remission on minimal steroid therapy by Week 60. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Time to Initial Flare/Relapse by Week 60
Description
Time to initial flare/relapse is time from Baseline to the time of appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. The appearance of 1 or 2 new lesions was not to be considered a flare/relapse. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Number of Participants Who do Not Flare/Relapse
Description
It was planned to assess participants with out an appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or an extension (worsening) of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Number of Participants Who do Not Flare/Relapse on Minimal Steroid Therapy
Description
It was planned to assess as participants who achieved remission on minimal steroid therapy and did not subsequently have a flare/relapse of disease by Week 60. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course
Description
It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course During the Individualized Follow-up Period
Description
It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 156
Title
Number of Days Minimal Steroid Therapy is Maintained by Week 60
Description
Minimal steroid therapy is an oral prednisone/prednisolone dose of <= 10 mg/day. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Number of Days a Participant is Off Steroid Therapy by Week 60
Description
Number of days, a participant did not require steroid therapy was observed and summarized. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Cumulative Dose of Corticosteroids
Description
Cumulative dose of corticosteroids was calculated to evaluate steroid exposure and reductions in steroid dose while maintaining disease control. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 60
Title
Number of Participants With Positive Human Anti-human Antibody (HAHA) Immune Response
Description
Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 72
Title
Titer of Human Anti-human Antibody
Description
Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.
Time Frame
Up to Week 72
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult with clinically documented diagnosis of PV.
Completed Study OPV116910 through Week 60 with one of the following outcomes:
Did not achieve remission by Week 60 of OPV116910. Achieved remission on a steroid dose >10 milligrams/day. Achieved remission on minimal steroid therapy, but is experiencing a disease flare/relapse while participating in the first year (yr)of the OPV116910 Individualized Follow up Period (It is recommended subjects are transitioned to the extension study before the steroid dose is increased).
A woman is eligible to enter the study if she:
Is of non-childbearing potential: documented as surgically sterile (bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion) or is postmenopausal without menses for >2 years. Women who are <2 years postmenopausal are required to have menopausal status confirmed by follicle-stimulating hormone (FSH) and estradiol levels at the baseline evaluation. If FSH and estradiol levels do not provide confirmation of menopause, subject will be considered to be of childbearing potential.
Is of childbearing potential, with a negative pregnancy test at baseline, and agrees to the consistent and correct use of acceptable methods of contraception (Highly-Effective Methods for Avoiding Pregnancy) during heterosexual intercourse, beginning when the subject provides informed consent and lasting until 12 months after last dose of ofatumumab SC.
Exclusion Criteria:
Past or current history of hypersensitivity to components of the investigational product or medically-significant adverse effects (including allergic reactions) from cetirizine (or antihistamine equivalent) or paracetamol/acetaminophen.
Prior treatment with any of the following within the specified periods:
Medication and Other Treatment Restrictions Prior to OPV117059 Baseline Any time- Ofatumumab (Intravenous), total body irradiation, bone marrow transplantation, anti CD4; 6 weeks -Live vaccine 8 weeks- Immunosuppressive or immunomodulatory agents, including: azathioprine, cyclosporine, dapsone, mycophenolate, methotrexate, tacrolimus 6 months- Cyclophosphamide, cladribine, plasmapheresis, immunoabsorption, or immunoglobulin therapy, alemtuzumab, mitoxantrone 18 months -Rituximab or other anti CD20 treatments
Confirmed PML or neurological findings potentially consistent with PML.
Evidence or history of clinically significant infection or medical condition including:
Chronic or ongoing active infectious disease requiring long term systemic treatment, including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, or active hepatitis C.
Positive test for hepatitis B surface antigen (HbsAg). For HbsAg negative, but hepatitis B core antibody positive (anti-HBc) (regardless of hepatitis B surface antibody [HbsAb] status), a hepatitis B virus deoxyribonucleic acid (HBV DNA) test will be performed and the subject will be excluded if results are positive. Consult with a physician experienced in the care and management of subjects with hepatitis B to manage/treat subjects who are anti HBc positive. Subjects who are anti-HBc positive and HBV DNA negative will continue to be monitored throughout the study.
History of positive serology for human immunodeficiency virus. Previous serious opportunistic or atypical infections. Prior history, or suspicion, of tuberculosis. A radiograph of the chest taken within 3 months before the first administration of investigational product suggests no evidence indicating current active tuberculosis or previous tuberculosis.
Past or current malignancy, except for: Cervical carcinoma Stage 1B or less; Noninvasive basal cell and squamous cell skin carcinoma; Cancer diagnoses with a duration of complete response (remission) >5 years.
Clinical chemistry and/or hematology laboratory values of clinical concern, in the investigator's opinion.
For subjects transitioning directly from the OPV116910 study, review central chemistry and hematology laboratory reports from the Week 48 through Week 56 visits of OPV116910.
For subjects transitioning from the Individualized Follow-up Period of OPV116910, review central chemistry and hematology laboratory reports from the most recent OPV116910 Individualized Follow-up visit. If the date of that laboratory report is more than 12 weeks from the extension study Screening visit, then the laboratory assessments need to be repeated.
For subjects with neutropenia (absolute neutrophil count <1 Giga units per liter, the neutropenia must resolve before the first dose of ofatumumab, which should occur within 4 weeks of the screening assessments.
Electrocardiogram (ECG) showing a clinically significant abnormality or showing a Corrected QT Interval (QTc) interval >=450 millisecond (msec) (>=480 msec for subjects with bundle branch block) (ECG will be obtained during Week 60 visit of OPV116910; Repeat ECG if more than 12 weeks have elapsed).
Significant concurrent, uncontrolled medical condition that could affect the subject's safety, impair the subject's reliable participation in the study, impair the evaluation of endpoints, or necessitate the use of medication not allowed by the protocol.
In the Investigator's opinion, there is a reason why the subject would not be eligible for this study (eg, the subject is unable to comply with the visit schedule).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
GSK Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris
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