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Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisPhase 3RITAZAREMNCT01697267

Rituximab Vasculitis Maintenance Study

A Phase 3 study testing Rituximab and Azathioprine in people with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis and Microscopic Polyangiitis, run by Cambridge University Hospitals NHS Foundation Trust at 38 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. Read more about this study

Who is it for?
Ages 15 years and older
What is being tested?
Rituximab and Azathioprine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
38 sitesin 10 countries
Study dates
Apr 2013to 21 Nov 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • A diagnosis of AAV [granulomatosis with polyangiitis or microscopic polyangiitis], according to the definitions of the Chapel Hill Consensus Conference
  • Current or historical PR3/MPO ANCA positivity by ELISA
  • Disease relapse defined by one major or three minor disease activity items on the Birmingham Vasculitis Activity Score for Wegeners (BVAS/WG), in patients that have previously achieved remission following at least 3 months of induction therapy, with a combination of glucocorticoids and an immunosuppressive agent (cyclophosphamide or methotrexate or rituximab or mycophenolate mofetil)
  • Written informed consent

Who cannot join

  • Age < 15 years (age < 18 years at centres that do not treat paediatric patients)
  • Exclusions related to medication:
  • Previous therapy with:
  • Any biological B cell depleting agent (such as rituximab or belimumab) within the past 6 months
  • Alemtuzumab or anti-thymocyte globulin (ATG) within the last 12 months
  • IVIg, infliximab, etanercept, adalimumab, abatacept or plasma exchange in past 3 months
Show all 20Show fewer
  • Any investigational agent within 28 days of screening, or 5 half lives of the investigational drug (whichever is longer)
  • Exclusions related to general health:
  • Significant or uncontrolled medical disease not related to AAV, which in the investigators opinion would preclude patient participation
  • Presence of another multisystem autoimmune disease, including Churg Strauss syndrome, systemic lupus erythematosus, anti-GBM disease, or cryoglobulinaemic vasculitis,
  • Any concomitant condition anticipated to likely require greater than 4 weeks per year of oral or systemic glucocorticoid use and which would preclude compliance with the glucocorticoid protocol (e.g. poorly-controlled asthma, COPD, psoriasis, or inflammatory bowel disease).
  • History of severe allergic or anaphylactic reactions to humanised or murine chimeric monoclonal antibodies
  • Known infection with HIV (HIV testing will not be a requirement for trial entry); a past or current history of hepatitis B virus or hepatitis C virus infection.
  • Ongoing or recent (last 12 months) evidence of active tuberculosis or known active infection (screening for tuberculosis is part of "standard of care" in patients with established AAV) or evidence of untreated latent tuberculosis. Screening for tuberculosis is as per local practice.
  • History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure.
  • Pregnancy or inadequate contraception in pre-menopausal women
  • Breast feeding or lactating
  • Exclusion criteria related to laboratory parameters:
  • Bone marrow suppression as evidenced by a total white count < 4 x109/l, haemoglobin < 7 gm/dl or platelet count < 100,000/μl
  • Aspartate aminotransferase or alanine aminotransferase or amylase > 2.5 times the upper limit of normal, unless attributed to vasculitis

Trial locations and contacts

38 sites in 10 countries.

38 sites in 10 countries

United Kingdom11 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2WB

  • Brighton and Sussex University Hospitals

    Brighton, BN2 5BE

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Russells Hall Hospital

    Dudley, DY1 2HQ

  • Ipswich Hospital

    Ipswich, IP4 5PD

  • Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW

  • Imperial College

    London, W12 0NN

  • James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Queen's Medical Centre Campus, Nottingham University Hosp

    Nottingham, NG7 2UH

  • University of Oxford

    Oxford, OX1 2JD

Other trials in United Kingdom

United States9 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Hospital for Special Surgery

    New York, New York, 10021

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

Japan7 sites

  • Chiba University

    Chiba, 263-8522

  • Okayama University

    Kita-ku, Okayama-ken, 700-0082

  • Kitano Hospital

    Kyoto, 606-8501

  • University of Miyazaki

    Miyazaki, 889-2192

  • Teikyo University

    Tokyo, 173-0003

  • Tokyo Metropolitan Geriatric

    Tokyo, 173-0015

  • Kyorin University school of medicine

    Tokyo, 192-0005

Other trials in Japan

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Canberra Hospital

    Garran, Australian Capital Territory

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

Other trials in Australia

Canada2 sites

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • Mount Sinai Hospital

    Toronto, Ontario, M5T 3L9

Other trials in Canada

New Zealand2 sites

  • Auckland City Hospital

    Grafton, Auckland, 1023

  • North Shore Hospital

    Westlake, Auckland

Other trials in New Zealand

Czechia1 site

  • General Faculty Hospital

    Prague

Other trials in Czechia

Ireland1 site

  • Cork University Hospital

    Cork

Other trials in Ireland

Italy1 site

  • University Hospital of Parma

    Parma, 43100

Other trials in Italy

Sweden1 site

  • Karolinska University Hospital

    Stockholm

Other trials in Sweden

About this study

Official title: An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis

Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating rituximab every six months stops the disease returning and is safe.

The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and whether it works better than the older treatments, azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. We should also learn useful information about the effects of rituximab on quality of life and economic measures. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab.

Read more

RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we anticipate that most will respond well. If their disease is under reasonable control after four months, further treatment with either rituximab (a single dose ever four months for two years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and azathioprine groups will then be compared. Patients will be in the trial for four years.

The study has been designed by members of the European Vasculitis Study group (EUVAS) and the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30 hospitals in Europe, the USA, Australia and Mexico.

RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health and by Roche/Genentech.

Read the detailed description

Patients will be recruited at the time of relapse. All will receive rituximab 375 mg/m2/week x 4 and glucocorticoids.

Those patients that achieve disease control (BVAS/WG ≤ 1 and daily prednisone dose ≤ 10 mg) by month 4 will be randomised to the rituximab or control remission maintenance groups.

Treatment is protocolised for the entire duration of the study, until the common close date, when the final patient recruited has completed 36 months within the study or until the patient has completed 48 months on study whichever the sooner. Patients in the rituximab arm will receive treatment until month 20, and those in the azathioprine arm until month 27.

Being tested
Rituximab, Azathioprine
Keywords
vasculitis, ANCA vasculitis, microscopic polyangiitis, granulomatosis, Wegener's, AAV, vasculitides
Medical subject headings
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Microscopic Polyangiitis, Granulomatosis with Polyangiitis, Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabBiological

    Also called Rituxan, MabThera

    Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20.

  • AzathioprineDrug

    Also called Imuran

    Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.

    The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily.

    If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%.

Study groups in NCT01697267
Study groupRoleWhat they receive
Rituximab MaintenanceExperimentalRituximab maintenance: 1g at 4, 8, 12, 16 \& 20 months with standardised steroid taper
Receives: Biological: Rituximab
Azathioprine MaintenanceActive comparatorAzathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation) (200 mg maximum daily dose). Azathioprine withdrawn at month 27.
Receives: Drug: Azathioprine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse-free Survival

    The primary efficacy outcome measure of the trial is relapse-free survival, where a relapse is either major or minor. The primary analysis will be a Cox regression model adjusted for the stratification factors (ANCA type, relapse severity and prednisone induction regimen) for the difference in the distribution of relapse-free survival between the rituximab arm and the azathioprine (control) arm (two-sided at α-level of 5%).

    Measured: Any patients who have not relapsed at up to a maximum of 4 years will be censored.

Secondary outcomes (15)

  1. Number of Participants in Remission at 24 and 48 Months

    Proportion of patients who maintain remission at 24 and 48 months

    Measured: 24 and 48 months

  2. Combined Damage Assessment Score (Disease Related Damage Assessment)

    Cumulative accrual of damage as measured by the combined damage assessment score (CDA). Each persistent or new occurrence of damage is given a score of 1. The cumulative accrual of damage is obtained by summing across the different types of damage to get an overall score (max score = 64).

    Measured: data in Rows represent the change from randomization (month 4) to months 12, 24, 36, and 48.

  3. Cumulative GC Exposure

    Cumulative glucocorticoid (GC) exposure during the trial. The trial had a common close out date when the final patient reached month 36 in the trial. Patients were followed until month 48 or the common close out date, whichever happened sooner. Therefore, follow up varied between 36 and 48 months. Cumulative glucocorticoid exposure is presented as a dose in mg for during the treatment period (up to month 24) and across the whole trial (until month 48 or common close out when the final patient reached month 36).

    Measured: Up to 48 months

  4. Severe Adverse Event Rate

    Severe adverse event (SAE) rate

    Measured: Up to 48 months

  5. Infection Rates

    Infection (treated with intravenous or oral antibiotics) rates

    Measured: Up to 4 years

  6. Health-related Quality of Life Using the SF-36 Physical Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 4 months

  7. Health-related Quality of Life Using the SF-36 Mental Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 4 months

  8. Health-related Quality of Life Using the SF-36 Physical Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 12 months

  9. Health-related Quality of Life Using the SF-36 Mental Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 12 months

  10. Health-related Quality of Life Using the SF-36 Physical Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 24 months

  11. Health-related Quality of Life Using the SF-36 Mental Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 24 months

  12. Health-related Quality of Life Using the SF-36 Physical Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 36 months

  13. Health-related Quality of Life Using the SF-36 Mental Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 36 months

  14. Health-related Quality of Life Using the SF-36 Physical Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 48 months

  15. Health-related Quality of Life Using the SF-36 Mental Composite

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2012 (estimated)
  2. Study startApr 2013
  3. Primary completion22 Nov 2018
  4. Study completion21 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01697267
Sponsor's protocol ID
RITAZAREM
Other IDs
2012-001102-14
Acronym
RITAZAREM
Status last verified
Feb 2022
First submitted
31 Aug 2012
Last updated
18 Mar 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Watts RA, Suppiah R, Merkel PA, Luqmani R. Systemic vasculitis--is it time to reclassify? Rheumatology (Oxford). 2011 Apr;50(4):643-5. doi: 10.1093/rheumatology/keq229. Epub 2010 Jul 20. No abstract available.

    PubMed 20647295

  • Falk RJ, Jennette JC. ANCA disease: where is this field heading? J Am Soc Nephrol. 2010 May;21(5):745-52. doi: 10.1681/ASN.2009121238. Epub 2010 Apr 15.

    PubMed 20395376

  • Watts RA, Scott DG. Epidemiology of the vasculitides. Curr Opin Rheumatol. 2003 Jan;15(1):11-6. doi: 10.1097/00002281-200301000-00003.

    PubMed 12496504

  • Booth AD, Almond MK, Burns A, Ellis P, Gaskin G, Neild GH, Plaisance M, Pusey CD, Jayne DR; Pan-Thames Renal Research Group. Outcome of ANCA-associated renal vasculitis: a 5-year retrospective study. Am J Kidney Dis. 2003 Apr;41(4):776-84. doi: 10.1016/s0272-6386(03)00025-8.

    PubMed 12666064

  • Jayne D, Rasmussen N, Andrassy K, Bacon P, Tervaert JW, Dadoniene J, Ekstrand A, Gaskin G, Gregorini G, de Groot K, Gross W, Hagen EC, Mirapeix E, Pettersson E, Siegert C, Sinico A, Tesar V, Westman K, Pusey C; European Vasculitis Study Group. A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies. N Engl J Med. 2003 Jul 3;349(1):36-44. doi: 10.1056/NEJMoa020286.

    PubMed 12840090

  • de Groot K, Harper L, Jayne DR, Flores Suarez LF, Gregorini G, Gross WL, Luqmani R, Pusey CD, Rasmussen N, Sinico RA, Tesar V, Vanhille P, Westman K, Savage CO; EUVAS (European Vasculitis Study Group). Pulse versus daily oral cyclophosphamide for induction of remission in antineutrophil cytoplasmic antibody-associated vasculitis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):670-80. doi: 10.7326/0003-4819-150-10-200905190-00004.

    PubMed 19451574

  • De Groot K, Rasmussen N, Bacon PA, Tervaert JW, Feighery C, Gregorini G, Gross WL, Luqmani R, Jayne DR. Randomized trial of cyclophosphamide versus methotrexate for induction of remission in early systemic antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2005 Aug;52(8):2461-9. doi: 10.1002/art.21142.

    PubMed 16052573

  • Wegener's Granulomatosis Etanercept Trial (WGET) Research Group. Etanercept plus standard therapy for Wegener's granulomatosis. N Engl J Med. 2005 Jan 27;352(4):351-61. doi: 10.1056/NEJMoa041884.

    PubMed 15673801

  • Seo P, Min YI, Holbrook JT, Hoffman GS, Merkel PA, Spiera R, Davis JC, Ytterberg SR, St Clair EW, McCune WJ, Specks U, Allen NB, Luqmani RA, Stone JH; WGET Research Group. Damage caused by Wegener's granulomatosis and its treatment: prospective data from the Wegener's Granulomatosis Etanercept Trial (WGET). Arthritis Rheum. 2005 Jul;52(7):2168-78. doi: 10.1002/art.21117.

    PubMed 15986348

  • Reff ME, Carner K, Chambers KS, Chinn PC, Leonard JE, Raab R, Newman RA, Hanna N, Anderson DR. Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood. 1994 Jan 15;83(2):435-45.

    PubMed 7506951

  • Jones RB, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh D, Walsh M, Westman K, Jayne DR; European Vasculitis Study Group. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010 Jul 15;363(3):211-20. doi: 10.1056/NEJMoa0909169.

    PubMed 20647198

  • Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.

    PubMed 20647199

  • Jones RB, Ferraro AJ, Chaudhry AN, Brogan P, Salama AD, Smith KG, Savage CO, Jayne DR. A multicenter survey of rituximab therapy for refractory antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum. 2009 Jul;60(7):2156-68. doi: 10.1002/art.24637.

    PubMed 19565480

  • Smith RM, Jones RB, Specks U, Bond S, Nodale M, Al-Jayyousi R, Andrews J, Bruchfeld A, Camilleri B, Carette S, Cheung CK, Derebail V, Doulton T, Ferraro A, Forbess L, Fujimoto S, Furuta S, Gewurz-Singer O, Harper L, Ito-Ihara T, Khalidi N, Klocke R, Koening C, Komagata Y, Langford C, Lanyon P, Luqmani R, McAlear C, Moreland LW, Mynard K, Nachman P, Pagnoux C, Peh CA, Pusey C, Ranganathan D, Rhee RL, Spiera R, Sreih AG, Tesar V, Walters G, Wroe C, Jayne D, Merkel PA; RITAZAREM co-investigators. Rituximab versus azathioprine for maintenance of remission for patients with ANCA-associated vasculitis and relapsing disease: an international randomised controlled trial. Ann Rheum Dis. 2023 Jul;82(7):937-944. doi: 10.1136/ard-2022-223559. Epub 2023 Mar 23.

    PubMed 36958796

  • Gopaluni S, Smith RM, Lewin M, McAlear CA, Mynard K, Jones RB, Specks U, Merkel PA, Jayne DR; RITAZAREM Investigators. Rituximab versus azathioprine as therapy for maintenance of remission for anti-neutrophil cytoplasm antibody-associated vasculitis (RITAZAREM): study protocol for a randomized controlled trial. Trials. 2017 Mar 7;18(1):112. doi: 10.1186/s13063-017-1857-z.

    PubMed 28270229

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab and Azathioprine in people with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis and Microscopic Polyangiitis, run by Cambridge University Hospitals NHS Foundation Trust at 38 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United Kingdom, United States, Japan, Australia, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free Survival (time frame: Any patients who have not relapsed at up to a maximum of 4 years will be censored.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01697267, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.

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