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Trial record 8 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus (VOYAGER)

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ClinicalTrials.gov Identifier: NCT00381810
Recruitment Status : Terminated (During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.)
First Posted : September 28, 2006
Results First Posted : December 18, 2009
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Interventions Drug: Rituximab
Drug: Methylprednisolone
Drug: Acetaminophen
Drug: Diphenhydramine
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
Period Title: Treatment and Safety Follow-up
Started 31
Completed 16
Not Completed 15
Period Title: B Cell Follow-up
Started 7 [1]
Completed 0
Not Completed 7
[1]
Participants only entered the B cell follow-up period if their peripheral B cells were depleted.
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
44.0  (12.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
20-64 years Number Analyzed 31 participants
31
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
28
  90.3%
Male
3
   9.7%
1.Primary Outcome
Title Percentage of Participants With at Least 1 Serious Adverse Event
Hide Description A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.
Time Frame Baseline to the end of the study (up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description:
Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Percentage of participants
35.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab 1000 mg
Hide Arm/Group Description Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
All-Cause Mortality
Rituximab 1000 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab 1000 mg
Affected / at Risk (%)
Total   11/31 (35.48%) 
Cardiac disorders   
Cardiac Failure Congestive  1  1/31 (3.23%) 
Angina Pectoris  1  1/31 (3.23%) 
Gastrointestinal disorders   
Enteritis  1  1/31 (3.23%) 
Vomiting  1  1/31 (3.23%) 
Lupus Enteritis  1  1/31 (3.23%) 
Megacolon  1  1/31 (3.23%) 
Mesenteric Vein Thrombosis  1  1/31 (3.23%) 
General disorders   
Pyrexia  1  1/31 (3.23%) 
Infections and infestations   
Appendicitis  1  1/31 (3.23%) 
Gastroenteritis  1  1/31 (3.23%) 
Lobar Pneumonia  1  2/31 (6.45%) 
Pneumonia  1  1/31 (3.23%) 
Postoperative Wound Infection  1  1/31 (3.23%) 
Psuedomonal Bacteraemia  1  1/31 (3.23%) 
Injury, poisoning and procedural complications   
Animal Bite  1  1/31 (3.23%) 
Pubic Rami Fracture  1  1/31 (3.23%) 
Incisional Hernia  1  1/31 (3.23%) 
Investigations   
International Normalised Ratio Increased  1  1/31 (3.23%) 
Metabolism and nutrition disorders   
Obesity  1  1/31 (3.23%) 
Hypovolaemia  1  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders   
Systemic Lupus Erythematosus  1  2/31 (6.45%) 
Nervous system disorders   
Cerebral Infarction  1  1/31 (3.23%) 
Headache  1  1/31 (3.23%) 
Psychiatric disorders   
Depression  1  1/31 (3.23%) 
Renal and urinary disorders   
Lupus Nephritis  1  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Chronic Obstructive Pulmonary Disease  1  1/31 (3.23%) 
Pulmonary Embolism  1  1/31 (3.23%) 
Pneumonitis  1  1/31 (3.23%) 
Pulmonary Heamorrhage  1  1/31 (3.23%) 
Vascular disorders   
Deep Vein Thrombosis  1  1/31 (3.23%) 
Hypotension  1  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab 1000 mg
Affected / at Risk (%)
Total   31/31 (100.00%) 
Blood and lymphatic system disorders   
Lymphopenia  1  2/31 (6.45%) 
Lymphadenopathy  1  2/31 (6.45%) 
Cardiac disorders   
Palpitations  1  3/31 (9.68%) 
Tachycardia  1  3/31 (9.68%) 
Endocrine disorders   
Cushingoid  1  2/31 (6.45%) 
Hypothyroidism  1  2/31 (6.45%) 
Eye disorders   
Vision Blurred  1  2/31 (6.45%) 
Gastrointestinal disorders   
Nausea  1  11/31 (35.48%) 
Vomiting  1  4/31 (12.90%) 
Diarrhoea  1  5/31 (16.13%) 
Abdominal Pain  1  2/31 (6.45%) 
Abdominal Pain Upper  1  2/31 (6.45%) 
Gastrooesophageal Reflux Disease  1  3/31 (9.68%) 
Abdominal Discomfort  1  2/31 (6.45%) 
Mouth Ulceration  1  3/31 (9.68%) 
Haemorrhoids  1  2/31 (6.45%) 
General disorders   
Pain  1  5/31 (16.13%) 
Chest Pain  1  3/31 (9.68%) 
Fatigue  1  5/31 (16.13%) 
Influenza like Illness  1  4/31 (12.90%) 
Oedema Peripheral  1  3/31 (9.68%) 
Pyrexia  1  2/31 (6.45%) 
Adverse Drug Reaction  1  2/31 (6.45%) 
Nodule  1  2/31 (6.45%) 
Infections and infestations   
Upper Respiratory Tract Infection  1  17/31 (54.84%) 
Sinusitis  1  15/31 (48.39%) 
Urinary Tract Infection  1  11/31 (35.48%) 
Gastroenteritis  1  5/31 (16.13%) 
Candidiasis  1  4/31 (12.90%) 
Oral Candidiasis  1  3/31 (9.68%) 
Bronchitis  1  4/31 (12.90%) 
Herpes Zoster  1  3/31 (9.68%) 
Herpes Virus Infection  1  2/31 (6.45%) 
Gastroenteritis Viral  1  2/31 (6.45%) 
Viral Pharyngitis  1  2/31 (6.45%) 
Fungal Infection  1  2/31 (6.45%) 
Injury, poisoning and procedural complications   
Fall  1  2/31 (6.45%) 
Procedural Pain  1  3/31 (9.68%) 
Contusion  1  2/31 (6.45%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/31 (22.58%) 
Pain in Extremity  1  3/31 (9.68%) 
Musculoskeletal Stiffness  1  2/31 (6.45%) 
Back Pain  1  2/31 (6.45%) 
Bursitis  1  3/31 (9.68%) 
Systemic Lupus Erythematosus  1  3/31 (9.68%) 
Muscle Spasms  1  3/31 (9.68%) 
Muscular Weakness  1  3/31 (9.68%) 
Osteoarthritis  1  2/31 (6.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin Papilloma  1  2/31 (6.45%) 
Nervous system disorders   
Headache  1  7/31 (22.58%) 
Migraine  1  4/31 (12.90%) 
Dizziness  1  2/31 (6.45%) 
Psychiatric disorders   
Anxiety  1  5/31 (16.13%) 
Depression  1  4/31 (12.90%) 
Sleep Disorder  1  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/31 (9.68%) 
Sinus Congestion  1  3/31 (9.68%) 
Oropharyngeal Pain  1  2/31 (6.45%) 
Dyspnoea  1  2/31 (6.45%) 
Pleurisy  1  2/31 (6.45%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  3/31 (9.68%) 
Dermatitis Contact  1  3/31 (9.68%) 
Rash  1  2/31 (6.45%) 
Photosensitivity Reaction  1  2/31 (6.45%) 
Urticaria  1  2/31 (6.45%) 
Vascular disorders   
Hypertension  1  5/31 (16.13%) 
Flushing  1  3/31 (9.68%) 
Raynaud's Phenomenon  1  2/31 (6.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Since study U2971g did not demonstrate efficacy, a decision was made not to evaluate efficacy in this study and only safety results were evaluated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications Specialist
Organization: Genentech, Inc.
Phone: 800 821-8590
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00381810     History of Changes
Other Study ID Numbers: U3389g
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: November 11, 2009
Results First Posted: December 18, 2009
Last Update Posted: August 1, 2017