Condition category
Circulatory System
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Karen Dahlsveen

ORCID ID

Contact details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
mycycmed@hermes.cam.ac.uk

Additional identifiers

EudraCT number

2006-001663-33

ClinicalTrials.gov number

Protocol/serial number

4509

Study information

Scientific title

Acronym

MYCYC

Study hypothesis

There is a clear need for improved therapy in antineutrophil cytoplasmic antibody (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.

Ethics approval

MREC approved on the 20/05/2008, ref: 07/H0606/136

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

140 new patients will be randomised to MMF 2g/day or a European consensus intravenous cyclophosphamide regimen, with the same prednisolone dosing. Following a 6-month induction course all patients will receive consensus remission maintenance treatment with azathioprine and prednisolone.

Intervention type

Drug

Phase

Phase III

Drug names

Mycophenolate mofetil, cyclophosphamide, azathioprine, prednisolone

Primary outcome measures

Remission rate by 6 months

Secondary outcome measures

1. Relapse rate at 18 months
2. Safety

Overall trial start date

12/03/2007

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. New diagnosis of ANCA-associated systemic vasculitis (AASV) (Wegener's granulomatosis [WG] or microscopic polyangiitis [MPA]) (within the previous six months)
2. Active disease (defined by at least one major or three minor BVAS 2003 items)
3. ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ
4. Written informed consent
5. Aged 5 years or older, either sex

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Planned sample size: 140; UK sample size: 20

Participant exclusion criteria

1. Previous treatment with:
1.1. MMF: more than two weeks ever
1.2. Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of intravenous (IV) CYC (15 mg/kg)
1.3. Rituximab or high dose intravenous immunoglobulin within the last twelve months
2. Active infection (including hepatitis B, C, human immunodeficiency virus [HIV] and tuberculosis)
3. Known hypersensitivity to MMF, azathioprine (AZA) or CYC
4. Cancer or an individual history of cancer (other than resected basal cell skin carcinoma)
5. Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
6. Any condition judged by the investigator that would cause the study to be detrimental to the patient
7. Any other multi-system autoimmune disease including Churg Strauss angiitis, systemic lupus erythematosus (SLE), anti-glomerular basement membrane (anti-GBM) disease and cryoglobulinaemia
8. Active serious digestive system disease (e.g., inflammatory bowel disease)
9. Patients with imminently life threatening vasculitis (diffuse alveolar haemorrhage, intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis)
10. Patients with rapidly progressive glomerulonephritis and declining renal function. Defined as estimated glomerular filtration rate (GFR) fall greater than 20% in previous two weeks.
11. GFR less than 15 ml/min at entry or on dialysis

Recruitment start date

12/03/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Industry

Funder name

Aspreva (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes