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VasculitisPhase 2/3MYCYCNCT00414128

Clinical Trial of Mycophenolate Versus Cyclophosphamide in ANCA Vasculitis

A Phase 2/3 study testing mycophenolate mofetil and cyclophosphamide in people with Vasculitis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Completed

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

Official record
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Trial summary

The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis. Read more about this study

Who is it for?
Any age
Conditions the study is for
Vasculitis
What is being tested?
mycophenolate mofetil and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2007to Feb 2013
Phase
Phase 2/3
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • New diagnosis of AASV (WG or MPA) (within the previous six months)
  • Active disease (defined by at least one major or three minor BVAS 2003 items, see appendix 1)
  • ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ (see appendix )
  • Written informed consent

Who cannot join

  • Previous treatment with:
  • MMF: more than two weeks ever.
  • Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of IV CYC (15mg/kg)
  • Rituximab or high dose intravenous immunoglobulin within the last twelve months
  • Active infection (including hepatitis B, C, HIV and tuberculosis).
  • Known hypersensitivity to MMF, AZA or CYC.
Show all 10Show fewer
  • Cancer or an individual history of cancer (other than resected basal cell skin carcinoma).
  • Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
  • Any condition judged by the investigator that would cause the study to be detrimental to the patient.
  • Any other multi-system autoimmune disease including Churg Strauss angiitis, SLE, anti GBM disease and cryoglobulinaemia.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Addenbrookes Hospital

    Cambridge, Cambridgeshire, CB22QQ

Other trials in United Kingdom

About this study

Official title: A Randomised Clinical Trial of Mycophenolate Mofetil Versus Cyclophosphamide for Remission Induction in ANCA Associated Vasculitis.

The purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of ANCA associated vasculitis.

Read the detailed description

There is a clear need for improved therapy in ANCA associated vasculitis where current treatments are toxic and contribute to poor outcomes. Conventional therapy combines cyclophosphamide with prednisolone but is associated with severe adverse events in 35%, early mortality, malignancy and infertility. Mycophenolate mofetil (MMF) is a newer immunosuppressive drug which has superior efficacy to azathioprine in solid organ transplantation. MMF is an effective alternative to cyclophosphamide in lupus nephritis. Open label studies and retrospective surveys point to the efficacy and low toxicity of MMF in vasculitis.

We hypothesise that MMF not be less effective than cyclophosphamide for remission induction in AASV. 140 new patients will be randomised to MMF 3g/day or a European consensus intravenous cyclophosphamide regimen, with the same prednisolone dosing. Following a six month induction course all patients will receive consensus remission maintenance treatment with azathioprine and prednisolone. The primary end-point will be remission rate by six months, secondary end-points include relapse rate at 18 months and safety. The trial will be conducted in 10 countries by members of the European Vasculitis Study Group (EUVAS). The trial duration will be 42 months (24 months recruitment, 18 months follow up).

Conditions
Vasculitis
Keywords
vasculitis, ANCA, mycophenolate mofetil, cyclophosphamide, Anti neutrophil cytoplasm antibody associated vasculitis
Medical subject headings
Vasculitis

What participants receive

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

  • mycophenolate mofetilDrug

    Also called Cellcept

    2-3g/day for 3-6 months, in tablet, capsule or liquid form

  • cyclophosphamideDrug

    Also called cytoxan

    intravenous cyclophosphamide, 15mg/kg with dose reductions according to age and renal function, for 3-6 months (6-10 doses total)

Study groups in NCT00414128
Study groupRoleWhat they receive
mycophenolate mofetilExperimentalMycophenolate mofetil for 3-6 months until in stable remission, dose 2-3g/day
Receives: Drug: mycophenolate mofetil
cyclophosphamideActive comparatorpulsed intravenous cyclophosphamide 15mg/kg for 3-6 months (6-10 doses)until in stable remission
Receives: Drug: cyclophosphamide

What is being measured

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

  1. Remission rates at 6 months

    Assessed by BVAS score of zero on 2 consecutive assessments

    Measured: 6 months

Timeline

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

  1. First posted21 Dec 2006 (estimated)
  2. Study startMar 2007
  3. Primary completionJul 2011
  4. Study completionFeb 2013

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00414128
Sponsor's protocol ID
MYCYC
Other IDs
Eudract: 2006-001663-33
Acronym
MYCYC
Status last verified
Dec 2013
First submitted
19 Dec 2006
Last updated
6 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Jones RB, Hiemstra TF, Ballarin J, Blockmans DE, Brogan P, Bruchfeld A, Cid MC, Dahlsveen K, de Zoysa J, Espigol-Frigole G, Lanyon P, Peh CA, Tesar V, Vaglio A, Walsh M, Walsh D, Walters G, Harper L, Jayne D; European Vasculitis Study Group (EUVAS). Mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA-associated vasculitis: a randomised, non-inferiority trial. Ann Rheum Dis. 2019 Mar;78(3):399-405. doi: 10.1136/annrheumdis-2018-214245. Epub 2019 Jan 5.

    PubMed 30612116

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing mycophenolate mofetil and cyclophosphamide in people with Vasculitis, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

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 10 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 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Remission rates at 6 months (time frame: 6 months). 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 NCT00414128, which also lists 1 linked publication.

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 6 Dec 2013.

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