A Phase 3 interventional study of Ofatumumab and Placebo in Pemphigus Vulgaris, sponsored by Novartis Pharmaceuticals. Terminated at 16 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is expressed only in B lymphocytes.
The purpose of this study was to evaluate the efficacy, tolerability, and safety of ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every 4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both Week 0 and Week 4) in subjects with PV. It was anticipated that with sustained B-cell depletion in the presence of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein) autoantibodies in PV, that clinical remission of the disease would result.
Novartis terminated the development of the PV program and this study was terminated for non-safety reasons
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's enrollment of 35 is above the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For Japan: Evidence or history of clinically significant infection or medical condition including: Pneumocystis pneumonia or interstitial pneumonia
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject received subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
Biological: Ofatumumab
Subject received subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
Biological: Placebo
Ofatumumab (human monoclonal antibody) was provided in prefilled glass syringes initial syringes contained 0.6ml (60mg) of concentration 100 mg/m: drug product subsequently modified to 0.4 mL (20mg) concentration (50mg/ML) drug product
Placebo to match the active doses will consist of prefilled glass syringes filled with normal saline.
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy
Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintenance of a dose \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks and maintenance of the status until Week 60.
Time frame: Baseline up to approximately 60 weeks
Duration of Remission on Minimal Steroid Therapy
Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day up to Week 60 was assessed.
Time frame: Baseline up to approximately 60 weeks
Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60
Percentage of subjects who achieved absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day for \> or = 8 weeks at Week 60 was assessed. Time to remission was not estimable.
Time frame: Week 60
Time to Remission While on Minimal Steroid Therapy by Week 60.
Time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintained dose at \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks by Week 60 was assessed
Time frame: Baseline up to approximately 60 weeks
Percentage of Subjects Achieving Remission While Off Steroid Therapy by Week 60
Percentage of subjects with initial reduction of all steroids for \>=8 weeks with an absence of new or nonhealing (established) lesions by Week 60 were to be assessed. All subjects remained on prednisone/prednisolone so this endpoint could not be analyzed.Time to remission off steroid therapy also could not be analyzed
Time frame: Baseline up to approximately 60 weeks
Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.
Number of days a subject maintained minimal steroid therapy (an oral prednisone/prednisolone dose of ≤10 mg/day in the absence of new or nonhealing lesions) by Week 60.
Time frame: Baseline up to approximately 60 weeks
Time to Initial Flare/Relapse by Week 60
Time from randomization to the time of appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
Time frame: Baseline up to approximately 60 weeks
Percentage of Participants With no Flare/Relapse by Week 60
Percentage of participants achieving absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day and did not subsequently have a appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
Time frame: Baseline up to approximately 60 weeks
Plasma Trough Concentrations of Ofatumumab
Only plasma (trough) concentrations of ofatumumab were presented
Time frame: 4 hours post baseline, Days 1-4,7,14, Weeks 4,8,12,16,20,24,36,48,52,56, up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Time frame: Baseline up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Time frame: Baseline up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Time frame: Baseline up to approximately 60 weeks
Largest Mean Decrease From Baseline for Immunoglobulin A, G and M
Immunoglobulins A, G and M were assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Time frame: Baseline up to approximately 60 weeks
Change From Baseline for CD19+ B Cell Count
CD19+ B cell count will be performed using Flow Cytometry
Time frame: Baseline up to approximately 60 weeks
| Milestone | Ofatumumab | Placebo |
|---|---|---|
| Started | 17 | 18 |
| Requiried individualized follow-up | 1 | 0 |
| Completed | 2 | 1 |
| Not completed | 15 | 17 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Study closed/terminated | 14 | 15 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintenance of a dose \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks and maintenance of the status until Week 60.
| participants | Ofatumumab | Placebo |
|---|---|---|
| Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy | 0 | 0 |
Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day up to Week 60 was assessed.
| days | Ofatumumab | Placebo |
|---|---|---|
| Duration of Remission on Minimal Steroid Therapy | 168.0 ± 73.33 | 122.0 ± NA |
Percentage of subjects who achieved absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day for \> or = 8 weeks at Week 60 was assessed. Time to remission was not estimable.
| percentage of participants | Ofatumumab | Placebo |
|---|---|---|
| Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60 | 17.6 | 5.6 |
Time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintained dose at \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks by Week 60 was assessed
| days | Ofatumumab | Placebo |
|---|---|---|
| Time to Remission While on Minimal Steroid Therapy by Week 60. | NA (57.0 to NA) | NA (NA to NA) |
Percentage of subjects with initial reduction of all steroids for \>=8 weeks with an absence of new or nonhealing (established) lesions by Week 60 were to be assessed. All subjects remained on prednisone/prednisolone so this endpoint could not be analyzed.Time to remission off steroid therapy also could not be analyzed
No measurements were reported for this outcome.
Number of days a subject maintained minimal steroid therapy (an oral prednisone/prednisolone dose of ≤10 mg/day in the absence of new or nonhealing lesions) by Week 60.
| days | Ofatumumab | Placebo |
|---|---|---|
| Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60. | 168 ± 73.33 | 122.0 ± NA |
Time from randomization to the time of appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
| days | Ofatumumab | Placebo |
|---|---|---|
| Time to Initial Flare/Relapse by Week 60 | 448 (NA to NA) | 169.0 (86.0 to 284.0) |
Percentage of participants achieving absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day and did not subsequently have a appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
| percentage of participants | Ofatumumab | Placebo |
|---|---|---|
| Week 2 no flare | 100.0 | 94.4 |
| Week 2 no new/nonhealing lesions | 47.1 | 22.2 |
| Week 4 no flare | 88.2 | 83.3 |
| Week 4 no new/nonhealing lesions | 47.1 | 38.9 |
| Week 6 no flare | 70.6 | 77.8 |
| Week 6 no new/nonhealing lesions | 41.2 | 33.3 |
| Week 8 no flare | 64.7 | 72.2 |
| Week 8 no new/nonhealing lesions | 35.3 | 33.3 |
| Week 12 no flare | 58.8 | 55.6 |
| Week 12 no new/nonhealing lesions | 35.3 | 16.7 |
| Week 16 no flare | 52.9 | 61.1 |
| Week 16 no new/nonhealing lesions | 23.5 | 16.7 |
| Week 20 no flare | 47.1 | 50.0 |
| Week 20 no new/nonhealing lesions | 29.4 | 16.7 |
| Week 24 no flare | 47.1 | 38.9 |
| Week 24 no new/nonhealing lesions | 35.3 | 16.7 |
| Week 28 no flare | 29.4 | 22.2 |
| Week 28 no new/nonhealing lesions | 17.6 | 11.1 |
| Week 32 no flare | 35.3 | 27.8 |
| Week 32 no new/nonhealing lesions | 17.6 | 5.6 |
| Week 36 no flare | 23.5 | 11.1 |
| Week 36 no new/nonhealing lesions | 5.9 | 5.6 |
| Week 40 no flare | 17.6 | 5.6 |
| Week 40 no new/nonhealing lesions | 11.8 | 0 |
| Week 44 no flare | 17.6 | 5.6 |
| Week 44 no new/nonhealing lesions | 5.9 | 0 |
| Week 48 no flare | 17.6 | 0 |
| Week 48 no new/nonhealing lesions | 0 | 0 |
| Week 52 no flare | 11.8 | 5.6 |
| Week 52 no new/nonhealing lesions | 11.8 | 0 |
| Week 56 no flare | 11.8 | 0 |
| Week 56 no new/nonhealing lesions | 5.9 | 0 |
| Week 60 no flare | 88.2 | 83.3 |
| Week 60 no new/nonhealing lesions | 52.9 | 33.3 |
Only plasma (trough) concentrations of ofatumumab were presented
| ng/mL | Ofatumumab |
|---|---|
| 4 hours post dose SS | 56.60 ± NA |
| Day 1 Steady State (SS) | 1917.50 ± NA |
| Day 2 Steady State (SS) | 2994.20 ± NA |
| Day 3 Steady State (SS) | 3553.80 ± NA |
| Day 4 Steady State (SS) | 3619.20 ± NA |
| Day 7 Steady State (SS) | 3434.90 ± NA |
| Day 14 Steady State (SS) | 2055.30 ± NA |
| Week 4 | 311.59 ± 278.011 |
| Week 4 SS | 1132.70 ± NA |
| Week 8 | 1253.60 ± 439.574 |
| Week 8 SS | 1456.95 ± 668.994 |
| Week 12 | 727.01 ± 430.834 |
| Week 12 SS | 900.00 ± 455.930 |
| Week 16 | 512.88 ± 377.189 |
| Week 16 SS | 1043.40 ± NA |
| Week 20 | 415.88 ± 303.307 |
| Week 20 SS | 720.10 ± 246.356 |
| Week 24 | 461.72 ± 437.717 |
| Week 24 SS | 686.10 ± 329.699 |
| Week 36 | 477.63 ± 378.112 |
| Week 36 SS | 931.20 ± NA |
| Week 48 | 352.95 ± 300.591 |
| Week 48 SS | 1230.40 ± NA |
| Week 52 SS | 897.30 ± NA |
| Week 56 | 436.40 ± 511.662 |
| Week 60 | 76.40 ± 32.244 |
| Early withdrawal | 925.91 ± 971.715 |
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
| Participants | Ofatumumab | Placebo |
|---|---|---|
| Baseline | 1 | 0 |
| Week 12 | 1 | 0 |
| Week 16 | — | 0 |
| Week 24 | 1 | 0 |
| Week 36 | 1 | 0 |
| Week 48 | 1 | 0 |
| Week 52 | 1 | 0 |
| Week 56 | 1 | 0 |
| Week 60/Early withdrawal | 0 | 0 |
| First 12 weeks of therapy | 1 | 0 |
| During on therapy period | 1 | 0 |
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
| Participants | Ofatumumab | Placebo |
|---|---|---|
| Baseline | 1 | 2 |
| Week 12 | 0 | 1 |
| Week 16 | — | 1 |
| Week 24 | 0 | 1 |
| Week 36 | 0 | 0 |
| Week 48 | 0 | 0 |
| Week 52 | 0 | 0 |
| Week 56 | 0 | 0 |
| Week 60/Early withdrawal | 0 | 2 |
| First 12 weeks of therapy | 1 | 3 |
| During on therapy period | 1 | 4 |
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
| Participants | Ofatumumab | Placebo |
|---|---|---|
| Baseline | 1 | 1 |
| Week 12 | 4 | 1 |
| Week 16 | — | 0 |
| Week 24 | 4 | 0 |
| Week 36 | 4 | 0 |
| Week 48 | 3 | 0 |
| Week 52 | 2 | 0 |
| Week 56 | 2 | 0 |
| Week 60/Early withdrawal | 6 | 2 |
| First 12 weeks of therapy | 4 | 1 |
| During on therapy period | 6 | 2 |
Immunoglobulins A, G and M were assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
| g/L | Ofatumumab | Placebo |
|---|---|---|
| Immunoglobulin A | -0.185 ± 0.1181 | -0.472 ± 0.7116 |
| Immunoglobulin G | -1.172 ± 0.9390 | -0.955 ± 0.6205 |
| Immunoglobulin M | -0.231 ± 0.1152 | -0.263 ± 0.3053 |
CD19+ B cell count will be performed using Flow Cytometry
| 10^9 cells/L | Ofatumumab | Placebo |
|---|---|---|
| Week 12 | -0.24940 ± 0.228704 | 0.03080 ± 0.072358 |
| Week 16 | — | 0.08000 ± NA |
| Week 24 | -0.28607 ± 0.265327 | -0.04022 ± 0.197867 |
| Week 36 | -0.20525 ± 0.052703 | -0.10033 ± 0.021385 |
| Week 48 | -0.19717 ± 0.061436 | -0.00200 ± NA |
| Week 52 | -0.16300 ± 0.023335 | 0.09600 ± NA |
| Week 56 | -0.16300 ± 0.023335 | 0.01000 ± NA |
| Week 60/Early withdrawal | -0.21403 ± 0.190282 | 0.00367 ± 0.190375 |
Collected over Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ofatumumab SC | 0/17 (0%) | 1/17 (5.9%) | 14/17 (82.4%) |
| Placebo | 0/18 (0%) | 1/18 (5.6%) | 8/18 (44.4%) |
| Event | Ofatumumab SC | Placebo |
|---|---|---|
| Hepatic enzyme increasedInvestigations | 1/17 | 0/18 |
| AngioedemaSkin and subcutaneous tissue disorders | 0/17 | 1/18 |
| Event | Ofatumumab SC | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 3/17 | 1/18 |
| ChillsGeneral disorders | 3/17 | 0/18 |
| PyrexiaGeneral disorders | 3/17 | 0/18 |
| FatigueGeneral disorders | 2/17 | 1/18 |
| Upper respiratory tract infectionInfections and infestations | 2/17 | 1/18 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/17 | 1/18 |
| HeadacheNervous system disorders | 2/17 | 0/18 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/17 | 0/18 |
| HypertensionVascular disorders | 2/17 | 1/18 |
| PainGeneral disorders | 0/17 | 2/18 |
| Age, Continuous(years) | Ofatumumab | Placebo | Total |
|---|---|---|---|
| Mean | 49.6 ± 8.70 | 47.1 ± 11.20 | 48.3 ± 10.0 |
| Sex: Female, Male(Participants) | Ofatumumab | Placebo | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 7 | 10 | 17 |
| Race/Ethnicity, Customized(Participants) | Ofatumumab | Placebo | Total |
|---|---|---|---|
| African American/African Heritage | 1 | 0 | 1 |
| American Indian or Alaskan Native | 1 | 2 | 3 |
| Asian - East Asian Heritage | 2 | 0 | 2 |
| Asian - Japanese Heritage | 1 | 1 | 2 |
| White - Arabic/North African Heritage | 2 | 1 | 3 |
| White - White/ Caucasian/ European Heritage | 10 | 14 | 24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Ran from Aug 2013 to primary completion in Apr 2016, 32 months.
Results were first posted in Jun 2019, 3 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ofatumumab