Trial Outcomes & Findings for A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus (NCT NCT00381810)
NCT ID: NCT00381810
Last Updated: 2017-08-01
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
Baseline to the end of the study (up to 52 weeks)
Results posted on
2017-08-01
Participant Flow
Participant milestones
| Measure |
Rituximab 1000 mg
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.
|
|---|---|
|
Treatment and Safety Follow-up
STARTED
|
31
|
|
Treatment and Safety Follow-up
COMPLETED
|
16
|
|
Treatment and Safety Follow-up
NOT COMPLETED
|
15
|
|
B Cell Follow-up
STARTED
|
7
|
|
B Cell Follow-up
COMPLETED
|
0
|
|
B Cell Follow-up
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Rituximab 1000 mg
n=31 Participants
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.
|
|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Age, Customized
20-64 years
|
31 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of the study (up to 52 weeks)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.
Outcome measures
| Measure |
Rituximab 1000 mg
n=31 Participants
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.
|
|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event
|
35.5 Percentage of participants
|
Adverse Events
Rituximab 1000 mg
Serious events: 11 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab 1000 mg
n=31 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.2%
1/31
|
|
Cardiac disorders
Angina Pectoris
|
3.2%
1/31
|
|
Gastrointestinal disorders
Enteritis
|
3.2%
1/31
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31
|
|
Infections and infestations
Appendicitis
|
3.2%
1/31
|
|
Infections and infestations
Gastroenteritis
|
3.2%
1/31
|
|
Infections and infestations
Lobar Pneumonia
|
6.5%
2/31
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Animal Bite
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Pubic Rami Fracture
|
3.2%
1/31
|
|
Investigations
International Normalised Ratio Increased
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
Obesity
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
3.2%
1/31
|
|
Nervous system disorders
Cerebral Infarction
|
3.2%
1/31
|
|
Renal and urinary disorders
Lupus Nephritis
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.2%
1/31
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.2%
1/31
|
|
Vascular disorders
Hypotension
|
3.2%
1/31
|
|
Gastrointestinal disorders
Lupus Enteritis
|
3.2%
1/31
|
|
Gastrointestinal disorders
Megacolon
|
3.2%
1/31
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
3.2%
1/31
|
|
General disorders
Pyrexia
|
3.2%
1/31
|
|
Infections and infestations
Postoperative Wound Infection
|
3.2%
1/31
|
|
Infections and infestations
Psuedomonal Bacteraemia
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
6.5%
2/31
|
|
Nervous system disorders
Headache
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Heamorrhage
|
3.2%
1/31
|
|
Psychiatric disorders
Depression
|
3.2%
1/31
|
Other adverse events
| Measure |
Rituximab 1000 mg
n=31 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
2/31
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.5%
2/31
|
|
Cardiac disorders
Palpitations
|
9.7%
3/31
|
|
Cardiac disorders
Tachycardia
|
9.7%
3/31
|
|
Endocrine disorders
Cushingoid
|
6.5%
2/31
|
|
Eye disorders
Vision Blurred
|
6.5%
2/31
|
|
Gastrointestinal disorders
Nausea
|
35.5%
11/31
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
4/31
|
|
Gastrointestinal disorders
Diarrhoea
|
16.1%
5/31
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.5%
2/31
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.5%
2/31
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
9.7%
3/31
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
6.5%
2/31
|
|
Gastrointestinal disorders
Mouth Ulceration
|
9.7%
3/31
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.5%
2/31
|
|
General disorders
Pain
|
16.1%
5/31
|
|
General disorders
Chest Pain
|
9.7%
3/31
|
|
General disorders
Fatigue
|
16.1%
5/31
|
|
General disorders
Influenza like Illness
|
12.9%
4/31
|
|
General disorders
Oedema Peripheral
|
9.7%
3/31
|
|
General disorders
Pyrexia
|
6.5%
2/31
|
|
General disorders
Adverse Drug Reaction
|
6.5%
2/31
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
54.8%
17/31
|
|
Infections and infestations
Sinusitis
|
48.4%
15/31
|
|
Infections and infestations
Urinary Tract Infection
|
35.5%
11/31
|
|
Infections and infestations
Gastroenteritis
|
16.1%
5/31
|
|
Infections and infestations
Candidiasis
|
12.9%
4/31
|
|
Infections and infestations
Oral Candidiasis
|
9.7%
3/31
|
|
Infections and infestations
Bronchitis
|
12.9%
4/31
|
|
Infections and infestations
Herpes Zoster
|
9.7%
3/31
|
|
Infections and infestations
Herpes Virus Infection
|
6.5%
2/31
|
|
Infections and infestations
Gastroenteritis Viral
|
6.5%
2/31
|
|
Infections and infestations
Viral Pharyngitis
|
6.5%
2/31
|
|
Infections and infestations
Fungal Infection
|
6.5%
2/31
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
2/31
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
9.7%
3/31
|
|
Injury, poisoning and procedural complications
Contusion
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.6%
7/31
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.5%
2/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
6.5%
2/31
|
|
Nervous system disorders
Headache
|
22.6%
7/31
|
|
Nervous system disorders
Migraine
|
12.9%
4/31
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31
|
|
Psychiatric disorders
Anxiety
|
16.1%
5/31
|
|
Psychiatric disorders
Depression
|
12.9%
4/31
|
|
Psychiatric disorders
Sleep Disorder
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.7%
3/31
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
9.7%
3/31
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.5%
2/31
|
|
Vascular disorders
Hypertension
|
16.1%
5/31
|
|
Vascular disorders
Flushing
|
9.7%
3/31
|
|
Vascular disorders
Raynaud's Phenomenon
|
6.5%
2/31
|
|
Endocrine disorders
Hypothyroidism
|
6.5%
2/31
|
|
General disorders
Nodule
|
6.5%
2/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER