A Phase 3 interventional study of Mycophenolate Mofetil Placebo and Mycophenolate Mofetil in Pemphigus Vulgaris, sponsored by Hoffmann-La Roche. Completed at 68 sites in 12 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening.
Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness.
The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's enrollment of 135 is above the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (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.
Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Barrier methods must always be supplemented with the use of a spermicide
Examples of contraceptive methods with a failure rate of \< 1% per year (highly effective contraceptive methods) include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices
Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the participant
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. In addition to male contraception, agreement to advise female partners of to use highly effective contraception during the study and for at least 12 months after the last dose of study treatment
Exclusion Criteria:
Women who are not (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have two negative results with a sensitivity of >/=25 milli-international units per milliliter (mIU/mL): one from a serum pregnancy test at Day -8 to Day -10 of screening and another from a urine pregnancy test at Day 1 prior to randomization
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).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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 reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive MMF orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants will also receive rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria have been met.
Drug: Mycophenolate Mofetil · Drug: Rituximab Placebo
Participants will receive rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria have been met. Participants will also receive MMF matching placebo orally twice daily Q12H from Day 1 to Week 52.
Drug: Mycophenolate Mofetil Placebo · Drug: Rituximab
MMF matching placebo will be administered orally Q12H.
MMF will be administered at a starting dose of 500 milligrams (mg) Q12H and the dose will be titrated to achieve a goal of 1 gram (gm) Q12H.
Also known as: MMF, CellCept
Rituximab will be administered at a dose of 1000 mg via IV infusion.
Also known as: MabThera/Rituxan
Rituximab matching placebo will be administered via IV infusion.
Also known as: MabThera/Rituxan
Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score
Time frame: From Baseline up to 52 Weeks (up to clinical cut-off date (CCOD) of 28 November 2018)
Cumulative Oral Corticosteroid Dose
Time frame: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Total Number of Protocol Defined Disease Flares
Disease flare is defined as appearance of three or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who has achieved disease control.
Time frame: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Time to Initial Sustained Complete Remission
Time frame: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Time to Protocol Defined Disease Flare
Disease flare is defined as the appearance of three or more new lesions a month that do not heal spontaneously within 1 week or by the extension of established lesions in a participant who has achieved disease control.
Time frame: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score
Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.
Time frame: From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
An adverse event is any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment. A serious adverse event is an adverse event that results in death or is life-threatening or requires/prolongs hospitalization or results in persistent/significant disability/incapacity or congenital abnormality/birth defect. Adverse events of Grade 3 of higher are severe and life-threatening adverse events CS-related adverse events - causality as determined by the investigator.
Time frame: Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Percentage of Participants With Anti-Drug Antibodies (ADA)
Participants with treatment-induced and treatment-enhanced anti-drug antibodies. The clinical relevance of anti-rituximab antibody formation in RITUXAN treated pemphigus vulgaris (PV) participants is unclear.
Time frame: Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
Time frame: Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018)
| Milestone | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Started | 67 | 68 |
| Completed | 66 | 58 |
| Not completed | 1 | 10 |
| Withdrew: Adverse event | 1 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 5 |
| Withdrew: Non-compliance with study drug | 0 | 1 |
| Milestone | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Started | 66 | 58 |
| Completed | 59 | 53 |
| Not completed | 7 | 5 |
| Withdrew: Lost to follow-up | 2 | 4 |
| Withdrew: Withdrawal by subject | 5 | 0 |
| Withdrew: Treated by not accepted treatment | 0 | 1 |
| Percentage of Participants | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score | 40.3 | 9.5 |
| milligram (mg) | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Cumulative Oral Corticosteroid Dose | 2775.00 (2146.88 to 3610.00) | 4005.00 (2662.50 to 5815.00) |
Disease flare is defined as appearance of three or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who has achieved disease control.
| Number of Flares | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Total Number of Protocol Defined Disease Flares | 6 | 44 |
| Weeks | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Time to Initial Sustained Complete Remission | NA (32.1 to NA) | NA (NA to NA) |
Disease flare is defined as the appearance of three or more new lesions a month that do not heal spontaneously within 1 week or by the extension of established lesions in a participant who has achieved disease control.
| Weeks | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Time to Protocol Defined Disease Flare | NA (NA to NA) | NA (36.9 to NA) |
Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.
| Scores on a Scale | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Baseline | 10.14 ± 7.89 | 11.09 ± 8.52 |
| Week 52 | -8.874 ± 0.532 | -6.002 ± 0.662 |
An adverse event is any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment. A serious adverse event is an adverse event that results in death or is life-threatening or requires/prolongs hospitalization or results in persistent/significant disability/incapacity or congenital abnormality/birth defect. Adverse events of Grade 3 of higher are severe and life-threatening adverse events CS-related adverse events - causality as determined by the investigator.
| Percentage of Participants | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Participants with AE | 85.1 | 88.2 |
| Participants with SAE | 22.4 | 14.7 |
| Participants with Corticosteroid (CS)-Related AE | 34.3 | 38.2 |
| Participants with CS-Related AE Grade 3 or higher | 1.5 | 7.4 |
Participants with treatment-induced and treatment-enhanced anti-drug antibodies. The clinical relevance of anti-rituximab antibody formation in RITUXAN treated pemphigus vulgaris (PV) participants is unclear.
| Percentage of Participants | Rituximab (RTX) |
|---|---|
| Percentage of Participants With Anti-Drug Antibodies (ADA) | 31.7 |
| Percentage of Participants | Rituximab (RTX) | Mycophenolate Mofetil (MMF) |
|---|---|---|
| Baseline (IgA) | 0 | 0 |
| Week 16 (IgA) | 0 | 1.8 |
| Week 24 (IgA) | 1.7 | 2.2 |
| Week 40 (IgA) | 0 | 2.7 |
| Week 52 (IgA) | 0 | 3.6 |
| Baseline (IgG) | 6.1 | 6.0 |
| Week 16 (IgG) | 9.8 | 1.8 |
| Week 24 (IgG) | 3.4 | 2.2 |
| Week 40 (IgG) | 3.5 | 0 |
| Week 52 (IgG) | 4.3 | 0 |
| Baseline (IgM) | 7.6 | 11.9 |
| Week 16 (IgM) | 24.6 | 23.2 |
| Week 24 (IgM) | 27.1 | 28.3 |
| Week 40 (IgM) | 29.8 | 24.3 |
| Week 52 (IgM) | 29.8 | 28.6 |
Collected over Treatment Period: From Baseline up to Week 52 (up to CCOD of 28 November 2018) Safety Follow-up Period: Approximately 1 year (up to CCOD of 29 October 2019). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rituximab (RTX) | 0/67 (0%) | 15/67 (22.4%) | 42/67 (62.7%) |
| Mycophenolate Mofetil (MMF) | 1/68 (1.5%) | 10/68 (14.7%) | 41/68 (60.3%) |
| RTX Safety Follow-up | 0/66 (0%) | 4/66 (6.1%) | 2/66 (3%) |
| MMF Safety Follow-up | 0/58 (0%) | 1/58 (1.7%) | 3/58 (5.2%) |
| Event | Rituximab (RTX) | Mycophenolate Mofetil (MMF) | RTX Safety Follow-up | MMF Safety Follow-up |
|---|---|---|---|---|
| INFUSION RELATED REACTIONInjury, poisoning and procedural complications | 3/67 | 1/68 | 0/66 | 0/58 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 1/67 | 2/68 | 0/66 | 0/58 |
| Neutrophilic dermatosisSkin and subcutaneous tissue disorders | 0/67 | 0/68 | 0/66 | 1/58 |
| Haemophagocytic lymphohistiocytosisImmune system disorders | 0/67 | 0/68 | 1/66 | 0/58 |
| Septic shockInfections and infestations | 0/67 | 0/68 | 1/66 | 0/58 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/67 | 0/68 | 1/66 | 0/58 |
| Cerebrovascular accidentNervous system disorders | 0/67 | 0/68 | 1/66 | 0/58 |
| SyncopeNervous system disorders | 0/67 | 0/68 | 1/66 | 0/58 |
| ABDOMINAL PAINGastrointestinal disorders | 1/67 | 0/68 | 0/66 | 0/58 |
| ILEUSGastrointestinal disorders | 1/67 | 0/68 | 0/66 | 0/58 |
| Event | Rituximab (RTX) | Mycophenolate Mofetil (MMF) | RTX Safety Follow-up | MMF Safety Follow-up |
|---|---|---|---|---|
| INFUSION RELATED REACTIONInjury, poisoning and procedural complications | 12/67 | 5/68 | 0/66 | 0/58 |
| HEADACHENervous system disorders | 10/67 | 6/68 | 0/66 | 0/58 |
| DIARRHOEAGastrointestinal disorders | 3/67 | 10/68 | 0/66 | 0/58 |
| LYMPHOPENIABlood and lymphatic system disorders | 8/67 | 1/68 | 0/66 | 0/58 |
| NASOPHARYNGITISInfections and infestations | 6/67 | 8/68 | 0/66 | 0/58 |
| ORAL CANDIDIASISInfections and infestations | 6/67 | 6/68 | 0/66 | 0/58 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 6/67 | 5/68 | 2/66 | 3/58 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 6/67 | 2/68 | 0/66 | 0/58 |
| BACK PAINMusculoskeletal and connective tissue disorders | 6/67 | 1/68 | 0/66 | 0/58 |
| COUGHRespiratory, thoracic and mediastinal disorders | 6/67 | 2/68 | 0/66 | 0/58 |
| Age, Continuous(Years) | Rituximab (RTX) | Mycophenolate Mofetil (MMF) | Total |
|---|---|---|---|
| Mean | 50.66 ± 12.98 | 46.34 ± 13.08 | 48.48 ± 13.16 |
| Sex: Female, Male(Participants) | Rituximab (RTX) | Mycophenolate Mofetil (MMF) | Total |
|---|---|---|---|
| Female | 35 | 38 | 73 |
| Male | 32 | 30 | 62 |
| Race/Ethnicity, Customized(Participants) | Rituximab (RTX) | Mycophenolate Mofetil (MMF) | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 21 | 34 |
| Not Hispanic or Latino | 45 | 41 | 86 |
| Not Stated | 8 | 5 | 13 |
| Unknown | 1 | 1 | 2 |
| Race/Ethnicity, Customized(Participants) | Rituximab (RTX) | Mycophenolate Mofetil (MMF) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 3 | 1 | 4 |
| Black or African American | 1 | 2 | 3 |
| White | 49 | 51 | 100 |
| Unknown | 14 | 13 | 27 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2015 to primary completion in Nov 2018, 42 months.
Results were first posted in Jan 2020, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rituximab