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A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Phase 3 trial testing Rituximab in Lupus Erythematosus, Systemic in 31 participants. Terminated before completion.
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 22 June 2006 |
| Primary completion | 31 July 2008 |
| Estimated completion | 29 February 2012 |
| Sites | 11 locations across United States |
Genentech, Inc. — full company profile →
Adults 16 to 75, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Rituximab 1000 mg | 35.5 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Rituximab 1000 mg |
|---|---|---|
| Lobar Pneumonia | Infections and infestations | — |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | — |
| Cardiac Failure Congestive | Cardiac disorders | — |
| Angina Pectoris | Cardiac disorders | — |
| Enteritis | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Appendicitis | Infections and infestations | — |
| Gastroenteritis | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Animal Bite | Injury, poisoning and procedural complications | — |
| Pubic Rami Fracture | Injury, poisoning and procedural complications | — |
| International Normalised Ratio Increased | Investigations | — |
| Obesity | Metabolism and nutrition disorders | — |
| Hypovolaemia | Metabolism and nutrition disorders | — |
| Cerebral Infarction | Nervous system disorders | — |
| Lupus Nephritis | Renal and urinary disorders | — |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | — |
| Deep Vein Thrombosis | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
| Lupus Enteritis | Gastrointestinal disorders | — |
| Megacolon | Gastrointestinal disorders | — |
| Mesenteric Vein Thrombosis | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Postoperative Wound Infection | Infections and infestations | — |
| Reaction | System | Rituximab 1000 mg |
|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | — |
| Sinusitis | Infections and infestations | — |
| Nausea | Gastrointestinal disorders | — |
| Urinary Tract Infection | Infections and infestations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Headache | Nervous system disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Fatigue | General disorders | — |
| Gastroenteritis | Infections and infestations | — |
| Anxiety | Psychiatric disorders | — |
| Hypertension | Vascular disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Influenza like Illness | General disorders | — |
| Candidiasis | Infections and infestations | — |
| Bronchitis | Infections and infestations | — |
| Migraine | Nervous system disorders | — |
| Depression | Psychiatric disorders | — |
| Palpitations | Cardiac disorders | — |
| Tachycardia | Cardiac disorders | — |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | — |
| Mouth Ulceration | Gastrointestinal disorders | — |
| Chest Pain | General disorders | — |
| Oedema Peripheral | General disorders | — |
| Oral Candidiasis | Infections and infestations | — |
| Herpes Zoster | Infections and infestations | — |
| Procedural Pain | Injury, poisoning and procedural complications | — |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | — |
| Bursitis | Musculoskeletal and connective tissue disorders | — |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | — |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | — |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | — |
| Flushing | Vascular disorders | — |
| Lymphopenia | Blood and lymphatic system disorders | — |
| Lymphadenopathy | Blood and lymphatic system disorders | — |
| Cushingoid | Endocrine disorders | — |
Most-reported serious reactions: Lobar Pneumonia, Systemic Lupus Erythematosus, Cardiac Failure Congestive, Angina Pectoris, Enteritis, Vomiting, Appendicitis, Gastroenteritis.
Data from ClinicalTrials.gov NCT00381810 adverse events section.
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing