Trial Outcomes & Findings for A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01 (NCT NCT00583557)
NCT ID: NCT00583557
Last Updated: 2013-08-07
Results Overview
SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2013-08-07
Participant Flow
Participant milestones
| Measure |
Belimumab 10 mg/kg
Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
|
|---|---|
|
Overall Study
STARTED
|
155
|
|
Overall Study
Received at Least 1 Dose Belimumab
|
153
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
| Measure |
Belimumab 10 mg/kg
Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Lack of Efficacy
|
31
|
|
Overall Study
Lack of Compliance
|
5
|
|
Overall Study
Other
|
5
|
|
Overall Study
Did not receive belimumab in LBRA99
|
2
|
Baseline Characteristics
A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
Baseline characteristics by cohort
| Measure |
Belimumab 10 mg/kg
n=153 Participants
|
|---|---|
|
Age Continuous
|
51.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsSEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=153 Participants
Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
|
|---|---|
|
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
Number of subjects with at least 1 AE
|
148 Particpants
|
|
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
Number of subjects with at least 1 Non-Serious AE
|
144 Particpants
|
|
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
Number of subjects with at least 1 Serious AE
|
47 Particpants
|
|
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
Number of subjects with an AE resulting in death
|
3 Particpants
|
SECONDARY outcome
Timeframe: up to 5 YearsNOT ANALYZED
Outcome measures
Outcome data not reported
Adverse Events
Belimumab 10 mg/kg
Serious events: 47 serious events
Other events: 144 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Belimumab 10 mg/kg
n=153 participants at risk
Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
3/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Cardiac disorders
Angina pectoris
|
2.0%
3/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Gastritis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Nausea
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
General disorders
Non-cardiac chest pain
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Appendicitis perforated
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Bronchitis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Diverticulitis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Epiglottitis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Gastritis bacterial
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Gastroenteritis viral
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Incision site infection
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Laryngitis fungal
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Pneumonia
|
2.0%
3/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Pyelonephritis
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Sepsis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Investigations
Weight decreased
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
3/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Hand deformity
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.9%
6/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Cerebellar infarction
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Dizziness
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Movement disorder
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Syncope
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Psychiatric disorders
Major depression
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Vascular disorders
Accelerated hypertension
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Vascular disorders
Peripheral ischaemia
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Vascular disorders
Vascular insufficiency
|
0.65%
1/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
Other adverse events
| Measure |
Belimumab 10 mg/kg
n=153 participants at risk
Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
10/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
9/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.7%
24/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
13/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.8%
12/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Nausea
|
10.5%
16/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
14/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
General disorders
Fatigue
|
13.7%
21/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
General disorders
Oedema peripheral
|
18.3%
28/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Immune system disorders
Seasonal allergy
|
10.5%
16/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Bronchitis
|
22.9%
35/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Gastroenteritis viral
|
7.2%
11/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Influenza
|
9.8%
15/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
18/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Sinusitis
|
25.5%
39/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Tooth abscess
|
5.9%
9/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Upper respiratory tract infection
|
34.6%
53/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Urinary tract infection
|
15.0%
23/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
13.7%
21/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.2%
8/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.9%
9/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
7.8%
12/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Investigations
Weight increased
|
6.5%
10/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.5%
10/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
43.1%
66/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.3%
31/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
5.2%
8/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
15.7%
24/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.2%
11/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.1%
20/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.2%
11/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.5%
10/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.2%
8/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.5%
36/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
6.5%
10/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
7.2%
11/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Dizziness
|
8.5%
13/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Nervous system disorders
Headache
|
15.0%
23/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Psychiatric disorders
Depression
|
9.8%
15/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Psychiatric disorders
Insomnia
|
9.2%
14/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
27/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.2%
8/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.9%
9/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
9/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Surgical and medical procedures
Tooth extraction
|
9.2%
14/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
|
Vascular disorders
Hypertension
|
15.0%
23/153 • Up to 5 years
Subjects in LBRA99 completed parent study LBRA01 (NCT00071812) during which they received belimumab (1, 4 or 10 mg/kg belimumab) for 6 mos or 1 yr.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee For multi-center trials, no investigator will be authorized to publish study results from an individual center until the earlier of the multi-center trial results are published or 12 months after the end or termination of the multi-center trial at all sites. All manuscripts and abstracts must be submitted to the sponsor for review least 30 days prior to submission for publication or for presentation at a scientific meeting. The sponsor may delay publication for up to 3 months.
- Publication restrictions are in place
Restriction type: OTHER