Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, RA
Brief 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.
Detailed description
This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).
Interventions
DRUGbelimumab
IV 10mg/kg Q28 days
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: 1. Have completed the LBRA01 trial. 2. Have achieved at least an ACR20 response at the end of LBRA01. Primary
Exclusion criteria
1. Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01. 2. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01. 3. Used prohibited medications during their participation in LBRA01. These medications include the following: * Other investigational agents. * Biologic response modifiers * Cyclophosphamide. * Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months). * 2 new DMARDs. * 1 new DMARD plus high dose prednisone \>10 mg/day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. | Up to 5 years | SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF). | up to 5 Years | NOT ANALYZED |
Countries
Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Belimumab 10 mg/kg | 153 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Did not receive belimumab in LBRA99 | 2 |
| Overall Study | Lack of Compliance | 5 |
| Overall Study | Lack of Efficacy | 31 |
| Overall Study | Other | 5 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Belimumab 10 mg/kg |
|---|---|
| Age Continuous | 51.1 years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 144 / 153 |
| serious Total, serious adverse events | 47 / 153 |
Outcome results
Primary
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
Time frame: Up to 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Belimumab 10 mg/kg | To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. | Number of subjects with at least 1 AE | 148 Particpants |
| Belimumab 10 mg/kg | 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 |
| Belimumab 10 mg/kg | To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. | Number of subjects with at least 1 Serious AE | 47 Particpants |
| Belimumab 10 mg/kg | 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
The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
NOT ANALYZED
Time frame: up to 5 Years