Trial Outcomes & Findings for Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study) (NCT NCT00147966)
NCT ID: NCT00147966
Last Updated: 2010-03-23
Results Overview
ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).
COMPLETED
PHASE2
24 participants
0 and 12 weeks
2010-03-23
Participant Flow
Participant milestones
| Measure |
Ritxumab
Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
Baseline characteristics by cohort
| Measure |
Ritxumab
n=24 Participants
Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 and 12 weeksACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).
Outcome measures
| Measure |
Ritxumab
n=24 Participants
Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
|
|---|---|
|
American College of Rheumatology (ACR) 20 at Week 12
|
12 participants
|
Adverse Events
Ritxumab
Serious adverse events
| Measure |
Ritxumab
n=24 participants at risk
Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Ritxumab
n=24 participants at risk
Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
|
|---|---|
|
Immune system disorders
Allergic reaction to detergent on hand and arm
|
4.2%
1/24
|
|
General disorders
Hot/cold flashes
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Contact dimities
|
4.2%
1/24
|
|
Vascular disorders
Edema
|
4.2%
1/24
|
|
Reproductive system and breast disorders
Excessive vaginal bleeding
|
4.2%
1/24
|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24
|
|
Vascular disorders
Deep venous thrombosis
|
4.2%
1/24
|
|
Vascular disorders
Leg small vessel bursting
|
4.2%
1/24
|
|
Vascular disorders
Spider veins
|
4.2%
1/24
|
|
Nervous system disorders
Headache
|
4.2%
1/24
|
|
Immune system disorders
Sinus headache
|
4.2%
1/24
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24
|
|
General disorders
Fatigue
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24
|
|
Reproductive system and breast disorders
Endometriosis
|
4.2%
1/24
|
|
Nervous system disorders
Insomnia
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
4.2%
1/24
|
|
General disorders
Fall
|
4.2%
1/24
|
|
Injury, poisoning and procedural complications
Lacerated forehead
|
4.2%
1/24
|
|
Gastrointestinal disorders
Hiatal hernia
|
4.2%
1/24
|
|
Surgical and medical procedures
Corrective surgery, hammer toes
|
4.2%
1/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place