Trial Outcomes & Findings for Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis (NCT NCT00048347)
NCT ID: NCT00048347
Last Updated: 2010-09-08
Results Overview
The primary endpoint is the percent of patients with a clinical response as defined by a drop in the Short Clinical Colitis Score (SCCAI) of at least 3 points from Week 0 to Week 12. Short Clinical Colitis Score (SCCAI): Bowel frequency(day0-3,night0-2),urgency(0-3),rectal bleeding(0-3),well being(0-4),extracolonic features(0-4), total score 0(best)-19(worst).
COMPLETED
PHASE2
18 participants
Baseline, Week 12
2010-09-08
Participant Flow
Participant milestones
| Measure |
Avonex
30 µg IM every week for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Avonex
30 µg IM every week for 12 weeks
|
|---|---|
|
Overall Study
Screen failure
|
2
|
Baseline Characteristics
Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Avonex
n=18 Participants
30 µg IM every week for 12 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age Continuous
|
39.4 years
STANDARD_DEVIATION 4.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12The primary endpoint is the percent of patients with a clinical response as defined by a drop in the Short Clinical Colitis Score (SCCAI) of at least 3 points from Week 0 to Week 12. Short Clinical Colitis Score (SCCAI): Bowel frequency(day0-3,night0-2),urgency(0-3),rectal bleeding(0-3),well being(0-4),extracolonic features(0-4), total score 0(best)-19(worst).
Outcome measures
| Measure |
Avonex
n=18 Participants
30 µg IM every week for 12 weeks
|
|---|---|
|
Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI)
|
63 Percent of participants
|
Adverse Events
Avonex
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Avonex
n=16 participants at risk
30 µg IM every week for 12 weeks
|
|---|---|
|
Gastrointestinal disorders
fever
|
62.5%
10/16 • Number of events 10
|
|
Blood and lymphatic system disorders
eosinophilia
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
paresthesias
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
epistaxis
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
headache
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
pilonidal cyst
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
palmar xeroderma
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
C. difficile colitis
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place