Trial Outcomes & Findings for Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris (NCT NCT02613910)
NCT ID: NCT02613910
Last Updated: 2017-06-14
Results Overview
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.
TERMINATED
PHASE3
1 participants
Up to Week 60
2017-06-14
Participant Flow
This study was a multicounty, multicenter, open-label extension study to assess the long-term efficacy and safety of ofatumumab subcutaneous (SC) injection in participants with pemphigus vulgaris (PV), who completed the core study period of study OPV116910.
The study consisted of a screening visit, followed by a 56-week treatment period, a 4-week follow-up visit and a minimum of 1 year (up to 2 years) of individualized follow-up. Only 1 participant was enrolled into the study due to study termination.
Participant milestones
| Measure |
Ofatumumab
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Ofatumumab
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Overall Study
Termination of study
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1
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Baseline Characteristics
Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris
Baseline characteristics by cohort
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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Age, Continuous
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NA Years
STANDARD_DEVIATION NA • n=5 Participants
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Sex: Female, Male
Female
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NA Participants
n=5 Participants
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Sex: Female, Male
Male
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NA Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population. No safety events were reported for the one participant enrolled.
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.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population. No safety events were reported for the one participant enrolled.
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.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Severe Adverse Events
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population. No adverse events related to ofatumumab were reported for the one participant enrolled.
Participants with AEs related to ofatumumab were to be summarized. No adverse events related to ofatumumab were reported for the one participant enrolled.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Adverse Events Related to Ofatumumab SC
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. One participant was enrolled into the study and was withdrawn early due to study termination. No SAEs or AESIs were reported for this participant.
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.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
Any SAE
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0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
Any AESI
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population.
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.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants Withdrawn Due to Treatment-related AEs
|
0 Participants
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PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Infections
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Post-injection Systemic Reactions
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population
Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Injection Site Reactions
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0 Participants
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PRIMARY outcome
Timeframe: Baseline (Week 0) and up to Week 60Population: Safety Population
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Week 0) and up to Week 60Population: Safety Population.
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
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Week 0) and up to Week 60Population: Safety Population.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population.
Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Vital Signs of Clinical Concern
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0 Participants
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PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
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Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population.
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.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to \<= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
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|---|---|
|
Number of Participants With Laboratory Results of Potential Clinical Concern
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 156Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 72Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 72Population: Safety Population. Due to the termination of this study, 0 participants were analyzed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Ofatumumab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER