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Monoclonal Antibodies
Belimumab for Rheumatoid Arthritis
Phase 2
Waitlist Available
Research Sponsored by Human Genome Sciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.
Eligible Conditions
- Rheumatoid Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
Secondary study objectives
The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
Side effects data
From 2016 Phase 3 trial • 738 Patients • NCT0071293328%
Headache
21%
Nasopharyngitis
19%
Diarrhoea
18%
Arthralgia
18%
Influenza
16%
Cough
14%
Back pain
12%
Urinary tract infection bacterial
11%
Viral upper respiratory tract infection
11%
Upper respiratory tract infection
10%
Pyrexia
9%
Urinary tract infection
9%
Hypertension
9%
Myalgia
9%
Nausea
8%
Abdominal pain upper
8%
Rash
8%
Abdominal pain
8%
Dizziness
8%
Fatigue
7%
Herpes zoster
7%
Insomnia
7%
Upper respiratory tract infection bacterial
7%
Gastritis
7%
Vomiting
7%
Depression
7%
Gastroenteritis
7%
Alopecia
7%
Bronchitis bacterial
7%
Pain in extremity
6%
Oedema peripheral
6%
Bronchitis
6%
Anaemia
6%
Oral herpes
6%
Pruritus
5%
Dyspepsia
5%
Hypotension
5%
Pharyngitis bacterial
5%
Non-cardiac chest pain
5%
Rhinitis allergic
2%
Cellulitis
2%
Lupus nephritis
2%
Pneumonia bacterial
1%
Leukopenia
1%
Pneumonia
1%
Thrombocytopenia
1%
Osteonecrosis
1%
Raynaud's phenomenon
1%
Lupus vasculitis
1%
Appendicitis
1%
Cholelithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belimumab 10mg/kg IV
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BelimumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belimumab
FDA approved
Find a Location
Who is running the clinical trial?
Human Genome Sciences Inc.Lead Sponsor
32 Previous Clinical Trials
8,820 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,602 Previous Clinical Trials
6,144,475 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
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