A Study Evaluating the Safety and Efficacy of Ristova (Rituximab) in Combination With Glucocorticoids in Patients With Wegener's Granulomatosis or Microscopic Polyangitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02115997
First received: April 14, 2014
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This is a perspective, phase IV, multi-center, single arm, open-label, intervent ional study in adult patients with Wegener's granulomatosis (granulomatosis with polyangiitis GPA) or microscopic polyangiitis. Patients will be treated with Ristova and glucocorticoids. Ristova will be administered by intravenous (IV) in fusion at a dose of 375 mg/m2 body surface area once weekly during Weeks 1 to 4.

Patients will also receive one or three pulses of methylprednisolone (1000 mg e ach), followed by a tapering dose of oral prednisolone (start dose of 1 mg per k ilogram per day). The dose of oral prednisone will be reduced as per evaluation by the investigator till the patient is completely off the drug. The patients wi ll be followed up for duration of 6 months from the date of starting Ristova the rapy with three follow-up visits at Days 52, 112 and 172. All adverse events occ urring during this period will be captured.


Condition Intervention Phase
Wegener's Granulomatosis, Microscopic Polyangiitis
Drug: methylprednisolone
Drug: prednisone
Drug: rituximab [Ristova]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AN OPEN LABEL, PROSPECTIVE, POST MARKETING STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF RITUXIMAB WITH GLUCOCORTICOIDS IN ADULT PATIENTS WITH WEGENER'S GRANULOMATOSIS OR MICROSCOPIC POLYANGITIS

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with Wegener's Granulomatosis (GPA) and microscopic polyangiitis achieving a Birmingham Vasculitis Activity Score for GPA (BVAS/WG) score of 0 and successful completion of the prednisone taper at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving BVAS/WG score of 0 during treatment with prednisone at a dose of less than 10 mg per day [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with refractory antineutrophil cytoplasmic antibodies-associated vasculitis (AAV) achieving BVAS/WG score of 0 and successful completion of the prednisone taper [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients who achieve and maintain partial remission (defined as having a BVAS/WG of 1 or 2) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of severe flares [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of limited flares [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ristova (rituximab) Drug: methylprednisolone
1 to 3 pulses of 1000 mg
Drug: prednisone
Tapered dose (start at 1 mg/kg) given daily until patients are off the drug.
Drug: rituximab [Ristova]
375 mg/m2 of body surface area given by intravenous infusion once weekly during Weeks 1 to 4.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >/= 18 years of age
  • Diagnosed with GPA or Microscopic polyangiitis according to the definitions of the Chapel Hill Consensus Conference
  • Patients with either newly diagnosed or relapsing disease
  • Active severe disease according to the BVAS/WG criteria of severe enough to require treatment with cyclophosphamide (CYC)
  • Positive for either PR3-ANCA or MPO-ANCA at the screening
  • Patients willing to use effective contraception during and for 1 year after the completion of Ristova therapy

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Patients in a severely immunocompromised state
  • Patients with severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
  • Patients having active severe infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
  • Patients who had a live vaccine fewer than 4 weeks before 1st dose of Ristova
  • Any other condition which puts the patient to undue risk for rituximab therapy as per local prescribing information or Investigator's judgment
  • Patients with any previous treatment with Rituximab
  • Patients with any previous treatment with Alemtuzumab
  • Patients who have had treatment with Infliximab within the previous 3 months
  • Patients who have had treatment with Adalimumab within the previous 2 months
  • Patients who have had treatment with Etanercept within the previous month
  • Patients with any other investigational medication within the previous month
  • Pregnant or breast feeding patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02115997

Contacts
Contact: Reference Study ID Number: ML28550 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
India
Not yet recruiting
Bangalore, India, 560079
Not yet recruiting
Chandigarh, India, 160 012
Not yet recruiting
Kolkata, India, 700099
Not yet recruiting
Mumbai, India, 400 053
Not yet recruiting
New Delhi, India, 110029
Not yet recruiting
New Delhi, India, 110017
Not yet recruiting
Vellore, India, 632004
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02115997     History of Changes
Other Study ID Numbers: ML28550
Study First Received: April 14, 2014
Last Updated: August 26, 2014
Health Authority: India: National Drug Controller General of India

Additional relevant MeSH terms:
Wegener Granulomatosis
Systemic Vasculitis
Microscopic Polyangiitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rituximab
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014