Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 14, 2014
Last updated: June 1, 2016
Last verified: June 2016
This is a perspective, phase IV, multi-center, single arm, open-label, interventional 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) infusion 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 each), followed by a tapering dose of oral prednisolone (start dose of 1 mg per kilogram 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 will be followed up for duration of 6 months from the date of starting Ristova therapy with three follow-up visits at Days 52, 112 and 172. All adverse events occurring 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

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: July 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT02115997

Contact: Reference Study ID Number: ML28550 888-662-6728 (U.S. and Canada)

Not yet recruiting
Bangalore, India, 560076
Mumbai, India, 400 053
New Delhi, India, 110017
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT02115997     History of Changes
Other Study ID Numbers: ML28550 
Study First Received: April 14, 2014
Last Updated: June 1, 2016
Health Authority: India: National Drug Controller General of India

Additional relevant MeSH terms:
Granulomatosis with Polyangiitis
Systemic Vasculitis
Microscopic Polyangiitis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016