NCT02556866

Brief Summary

Multicenter randomized double-blind study comparing the efficacy and safety of rituximab in combination with corticosteroids to corticosteroids plus placebo in the treatment of non-infectious active mixed cryoglobulinemia vasculitis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

2.9 years

First QC Date

July 20, 2015

Last Update Submit

March 14, 2019

Conditions

CryoglobulinemiaSystemic Vasculitis

Outcome Measures

Primary Outcomes (1)

  • Complete clinical response of vasculitis symptoms (yes-no, i.e. success-failure) with corticosteroid withdrawal (prednisone at 0 mg/day) at week (W) 24, with at least one clinical response at W4

    The complete clinical response is defined by the remission of all affected organs involved at baseline and the absence of clinical relapse.

    Week 24

Secondary Outcomes (1)

  • Partial clinical response

    Week 24

Other Outcomes (15)

  • Evolution of cryoglobulinemia (positive or negative)

    Week 24

  • Evolution of C4 complement fraction (mg/L)

    Week 24

  • Rate of early failures

    Week 4

  • +12 more other outcomes

Study Arms (2)

rituximab

EXPERIMENTAL

Prednisone treatment plus rituximab administered by slow intravenous infusion at 375 mg/m2 at D1, D8, D15 and D22.

Drug: rituximabDrug: Prednisone

placebo

PLACEBO COMPARATOR

Prednisone treatment plus placebo administered by slow intravenous infusion at day 1 (D1), D8, D15 and D22.

Drug: PrednisoneDrug: Placebo

Interventions

rituximabDRUG

Prednisone treatment plus rituximab administered by slow intravenous infusion at 375 mg/m2 at D1, D8, D15 and D22.

rituximab
PrednisoneDRUG
placeborituximab
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be at least 18 years of age or older, without any upper age limit
  • Patient informed and agreed to participate, and gave informed consent,
  • Patient with active cryoglobulinemia vasculitis define by positive cryoglobulinemia and a clinically active vasculitis with skin, joint, renal, peripheral nerve, central neurological, digestive, pulmonary and/or cardiac involvement (no histological evidence needed if presence of purpura demonstrated),
  • Patient with primary Sjögren's syndrome, systemic lupus erythematosus, or another auto-immune disease, or B-cell non-Hodgkin lymphoma (with cryoglobulinemia as the only therapeutic indication), or essential mixed cryoglobulinemia,

You may not qualify if:

  • Patient with a medium and small size vessels vasculitis unrelated to cryoglobulinemia (granulomatous with polyangiitis (Wegener's disease), microscopic polyangiitis, eosinophilic granulomatous with polyangiitis (Churg-Strauss syndrome), polyarteritis nodose, IgA vasculitis, hypersensitivity vasculitis, infectious vasculitis, hypocomplementemic urticarial vasculitis),
  • Patient with a large size vessels vasculitis,
  • Patient with non active cryoglobulinemia vasculitis,
  • Pregnancy in progress or needed , breast feeding,
  • HIV-positive status,
  • Patient with active hepatitis B or C infection,
  • HBs Ag-positive and/or HBV DNA detectable in the blood\*,
  • Patients with known hypersensitivity reaction to the active substance or any of the excipients, or to murine proteins,
  • Contraindication to rituximab,
  • Active infections at screening,
  • Patient in guardianship,
  • Patient already included in a biomedical research protocol,
  • No social security scheme (Beneficiaries or eligible),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié Salpetriere Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

CryoglobulinemiaSystemic Vasculitis

Interventions

RituximabPrednisone

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmunoproliferative DisordersImmune System DiseasesVasculitis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Patrice CACOUB, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

September 22, 2015

Study Start

July 17, 2015

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

FR(1)