A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01

• Sponsor: Human Genome Sciences Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00583557
• Collaborator: (none)
• Enrollment: 155
• Locations: 48
• Arm: 1
• Duration (Months): 58
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: belimumab	Phase 2

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 155 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belimumab	Drug: belimumab; IV 10mg/kg Q28 days; Other Names: LymphoStat-B™

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Arizona Arthritis Research	Paradise Valley	Arizona	United States	85253
3	Arthritis Health	Scottsdale	Arizona	United States	85260
4	The University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724
5	University of Southern CA	Los Angeles	California	United States	90033
6	Wallace Rheumatic Disease Center	Los Angeles	California	United States	90048
7	Boling Clinical Trials	Rancho Cucamonga	California	United States	91730
8	Arthritis Care Center, Inc.	San Jose	California	United States	95126
9	Arthritis Associates & Osteoporosis Center of Colorado Springs	Colorado Springs	Colorado	United States	80910
10	Washington Hospital Center	Washington, DC	District of Columbia	United States	20010
11	Arthritis and Rheumatic Disease Specialties	Aventura	Florida	United States	33180
12	Rheumatology Associates of Central Florida	Orlando	Florida	United States	32806
13	Tampa Medical Group, P.A.	Tampa	Florida	United States	33614
14	Radiant Research Boise	Boise	Idaho	United States	83704
15	Rheumatology Associates	Chicago	Illinois	United States	60612
16	Medical Specialists	Munster	Indiana	United States	46321
17	Kentuckiana Center for Better Bone and Joint Health	Louisville	Kentucky	United States	40202
18	The Osteoporosis and Arthritis Clinical Trial Center	Cumberland	Maryland	United States	21502
19	Center for Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
20	Mayo Clinic	Rochester	Minnesota	United States	55905
21	Washington University in St. Louis	St. Louis	Missouri	United States	63110
22	Arthritis Center of Nebraska	Lincoln	Nebraska	United States	68506
23	Strafford Medical Associates, P.A.	Dover	New Hampshire	United States	03820
24	The Center for Rheumatology	Albany	New York	United States	12206
25	North Shore University Hospital	Manhasset	New York	United States	11030
26	Arthritis Clinic and Carolina Bone and Joint	Charlotte	North Carolina	United States	28210
27	Wake Forest Unviersity School of Medicine	Winston-Salem	North Carolina	United States	27599-7280
28	Bone and Joint Hospital - Research Department	Oklahoma City	Oklahoma	United States	73103
29	Oklahoma Medical Reseach Foundation	Oklahoma City	Oklahoma	United States	74114
30	Oklahoma Center for Arthritis Therapy & Research	Tulsa	Oklahoma	United States	74114
31	University of Pittsburgh School of Medicine & ASPH	Pittsburgh	Pennsylvania	United States	15261
32	Rheumatic Disease Associates	Willow Grove	Pennsylvania	United States	19090
33	Arthritis Centers of Texas	Dallas	Texas	United States	75246
34	UT Southwestern Medical Center at Dallas	Dallas	Texas	United States	75390-8884
35	Houston Institute for Clinical Research	Houston	Texas	United States	77074
36	Texas Research Center	Sugar Land	Texas	United States	77479
37	IPC Clinical Research	Ogden	Utah	United States	84403
38	Arthritis Clinic of Northern Virginia, P.C.	Arlington	Virginia	United States	22205
39	Seattle Arthritis Clinic	Seattle	Washington	United States	98133
40	Arthritis Northwest Rheumatology	Spokane	Washington	United States	99204
41	Rheumatology Northwest Clinical Trials	Yakima	Washington	United States	98902
42	Rheumatic Disease Center	Glendale	Wisconsin	United States	53217
43	Gundersen Clinic, LTD	La Crosse	Wisconsin	United States	54610
44	Marshfield Medical Research Foundation	Wausau	Wisconsin	United States	54401
45	NZOZ Centrum Medyczne	Bialystok		Poland
46	Wojewodzki Zespol Reumatologiczny	Sopot		Poland
47	Instytut Reumaologii	Warszawa		Poland
48	Instytut Reumatologii	Warszawa		Poland

Sponsors and Collaborators

• Human Genome Sciences Inc.

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• ClinicalTrials.gov Posting for Parent Protocol LBRA01

Publications

None provided.

• Responsible Party: Human Genome Sciences Inc.
• ClinicalTrials.gov Identifier: NCT00583557
• Other Study ID Numbers: LBRA99
• First Posted: Dec 31, 2007
• Last Update Posted: Aug 7, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Human Genome Sciences Inc.: Rheumatoid Arthritis; RA
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Belimumab

Study Results

Participant Flow

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
Period Title: Overall Study
STARTED	155
Received at Least 1 Dose Belimumab	153
COMPLETED	85
NOT COMPLETED	70

Baseline Characteristics

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description
Overall Participants	153
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.1 (8.9)
Sex: Female, Male (Count of Participants)
Female	118 77.1%
Male	35 22.9%

Outcome Measures

1. Primary Outcome

Title	To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
Description	SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
Measure Participants	153
Number of subjects with at least 1 AE	148
Number of subjects with at least 1 Non-Serious AE	144
Number of subjects with at least 1 Serious AE	47
Number of subjects with an AE resulting in death	3

2. Secondary Outcome

Title	The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
Description	NOT ANALYZED
Time Frame	up to 5 Years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Up to 5 years
Adverse Event Reporting Description	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.
Arm/Group Title	Belimumab 10 mg/kg
Arm/Group Description	Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
All Cause Mortality
	Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	47/153 (30.7%)
Blood and lymphatic system disorders
Anaemia	3/153 (2%)
Cardiac disorders
Angina pectoris	3/153 (2%)
Arteriosclerosis coronary artery	1/153 (0.7%)
Coronary artery disease	2/153 (1.3%)
Coronary artery thrombosis	1/153 (0.7%)
Gastrointestinal disorders
Abdominal distension	1/153 (0.7%)
Abdominal pain	1/153 (0.7%)
Colitis ulcerative	1/153 (0.7%)
Diarrhoea	1/153 (0.7%)
Diverticulum intestinal	1/153 (0.7%)
Gastric haemorrhage	1/153 (0.7%)
Gastritis	1/153 (0.7%)
Hiatus hernia	1/153 (0.7%)
Irritable bowel syndrome	1/153 (0.7%)
Nausea	1/153 (0.7%)
Obstruction gastric	1/153 (0.7%)
Upper gastrointestinal haemorrhage	1/153 (0.7%)
Vomiting	1/153 (0.7%)
General disorders
Non-cardiac chest pain	2/153 (1.3%)
Hepatobiliary disorders
Cholecystitis acute	1/153 (0.7%)
Infections and infestations
Appendicitis perforated	1/153 (0.7%)
Bacterial pyelonephritis	1/153 (0.7%)
Bronchitis	1/153 (0.7%)
Diverticulitis	1/153 (0.7%)
Epiglottitis	1/153 (0.7%)
Escherichia bacteraemia	1/153 (0.7%)
Gastritis bacterial	1/153 (0.7%)
Gastroenteritis	2/153 (1.3%)
Gastroenteritis viral	1/153 (0.7%)
Incision site infection	1/153 (0.7%)
Laryngitis fungal	1/153 (0.7%)
Meningitis pneumococcal	1/153 (0.7%)
Mycobacterium avium complex infection	1/153 (0.7%)
Pneumonia	3/153 (2%)
Pyelonephritis	2/153 (1.3%)
Sepsis	1/153 (0.7%)
Urinary tract infection	1/153 (0.7%)
Injury, poisoning and procedural complications
Contusion	1/153 (0.7%)
Dislocation of vertebra	1/153 (0.7%)
Head injury	1/153 (0.7%)
Hip fracture	1/153 (0.7%)
Lumbar vertebral fracture	1/153 (0.7%)
Post procedural haematoma	1/153 (0.7%)
Tibia fracture	1/153 (0.7%)
Upper limb fracture	1/153 (0.7%)
Investigations
Weight decreased	1/153 (0.7%)
Metabolism and nutrition disorders
Dehydration	2/153 (1.3%)
Diabetes mellitus inadequate control	1/153 (0.7%)
Diabetic ketoacidosis	1/153 (0.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/153 (2%)
Arthritis	1/153 (0.7%)
Cervical spinal stenosis	1/153 (0.7%)
Hand deformity	1/153 (0.7%)
Intervertebral disc degeneration	1/153 (0.7%)
Intervertebral disc disorder	1/153 (0.7%)
Intervertebral disc protrusion	2/153 (1.3%)
Joint instability	2/153 (1.3%)
Lumbar spinal stenosis	2/153 (1.3%)
Musculoskeletal chest pain	1/153 (0.7%)
Musculoskeletal pain	1/153 (0.7%)
Osteoarthritis	6/153 (3.9%)
Osteonecrosis	1/153 (0.7%)
Osteoporotic fracture	1/153 (0.7%)
Rheumatoid arthritis	2/153 (1.3%)
Spinal osteoarthritis	1/153 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer	1/153 (0.7%)
Nervous system disorders
Cerebellar infarction	1/153 (0.7%)
Cerebrovascular accident	1/153 (0.7%)
Cervicobrachial syndrome	1/153 (0.7%)
Dizziness	1/153 (0.7%)
Lumbar radiculopathy	1/153 (0.7%)
Movement disorder	1/153 (0.7%)
Syncope	1/153 (0.7%)
Transient ischaemic attack	2/153 (1.3%)
Psychiatric disorders
Major depression	1/153 (0.7%)
Obsessive-compulsive disorder	1/153 (0.7%)
Renal and urinary disorders
Acute prerenal failure	1/153 (0.7%)
Reproductive system and breast disorders
Cervical dysplasia	1/153 (0.7%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/153 (1.3%)
Dyspnoea	2/153 (1.3%)
Dyspnoea exertional	1/153 (0.7%)
Pneumonia aspiration	1/153 (0.7%)
Pulmonary fibrosis	1/153 (0.7%)
Respiratory failure	1/153 (0.7%)
Vascular disorders
Accelerated hypertension	1/153 (0.7%)
Peripheral ischaemia	1/153 (0.7%)
Vascular insufficiency	1/153 (0.7%)
Other (Not Including Serious) Adverse Events
	Belimumab 10 mg/kg
	Affected / at Risk (%)	# Events
Total	144/153 (94.1%)
Blood and lymphatic system disorders
Anaemia	10/153 (6.5%)
Gastrointestinal disorders
Abdominal pain	9/153 (5.9%)
Diarrhoea	24/153 (15.7%)
Dyspepsia	13/153 (8.5%)
Gastrooesophageal reflux disease	12/153 (7.8%)
Nausea	16/153 (10.5%)
Vomiting	14/153 (9.2%)
General disorders
Fatigue	21/153 (13.7%)
Oedema peripheral	28/153 (18.3%)
Immune system disorders
Seasonal allergy	16/153 (10.5%)
Infections and infestations
Bronchitis	35/153 (22.9%)
Gastroenteritis viral	11/153 (7.2%)
Influenza	15/153 (9.8%)
Nasopharyngitis	18/153 (11.8%)
Sinusitis	39/153 (25.5%)
Tooth abscess	9/153 (5.9%)
Upper respiratory tract infection	53/153 (34.6%)
Urinary tract infection	23/153 (15%)
Viral upper respiratory tract infection	21/153 (13.7%)
Injury, poisoning and procedural complications
Contusion	8/153 (5.2%)
Excoriation	9/153 (5.9%)
Skin laceration	12/153 (7.8%)
Investigations
Weight increased	10/153 (6.5%)
Metabolism and nutrition disorders
Hypercholesterolaemia	10/153 (6.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	66/153 (43.1%)
Back pain	31/153 (20.3%)
Bursitis	8/153 (5.2%)
Joint swelling	24/153 (15.7%)
Muscle spasms	11/153 (7.2%)
Musculoskeletal pain	20/153 (13.1%)
Myalgia	11/153 (7.2%)
Neck pain	10/153 (6.5%)
Osteopenia	8/153 (5.2%)
Pain in extremity	36/153 (23.5%)
Rheumatoid nodule	10/153 (6.5%)
Synovitis	11/153 (7.2%)
Nervous system disorders
Dizziness	13/153 (8.5%)
Headache	23/153 (15%)
Psychiatric disorders
Depression	15/153 (9.8%)
Insomnia	14/153 (9.2%)
Respiratory, thoracic and mediastinal disorders
Cough	27/153 (17.6%)
Nasal congestion	8/153 (5.2%)
Sinus congestion	9/153 (5.9%)
Skin and subcutaneous tissue disorders
Rash	9/153 (5.9%)
Surgical and medical procedures
Tooth extraction	14/153 (9.2%)
Vascular disorders
Hypertension	23/153 (15%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.