Trial Outcomes & Findings for Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease (NCT NCT00349752)
NCT ID: NCT00349752
Last Updated: 2018-08-09
Results Overview
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
TERMINATED
PHASE3
174 participants
Week 38
2018-08-09
Participant Flow
A Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Subjects With Moderate to Severe Crohn's Disease from November 2006 to July 2009
Participant milestones
| Measure |
Certolizumab Pegol 400 mg
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
87
|
|
Overall Study
COMPLETED
|
28
|
23
|
|
Overall Study
NOT COMPLETED
|
59
|
64
|
Reasons for withdrawal
| Measure |
Certolizumab Pegol 400 mg
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
12
|
|
Overall Study
Lack of Efficacy
|
37
|
42
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Personal reasons
|
6
|
5
|
|
Overall Study
Other: Required exclusionary medication
|
0
|
1
|
|
Overall Study
Other: Non compliance
|
0
|
1
|
|
Overall Study
Other: Patient stopped steroids
|
0
|
1
|
|
Overall Study
Other: Patient's steroid use
|
1
|
0
|
|
Overall Study
Other: Ineligible
|
1
|
0
|
|
Overall Study
Other: Inadvertently unblinded
|
1
|
0
|
|
Overall Study
Other:History of squamous cell carcinoma
|
1
|
0
|
Baseline Characteristics
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
Baseline characteristics by cohort
| Measure |
Certolizumab Pegol 400 mg
n=87 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=87 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
40.77 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
39.73 years
STANDARD_DEVIATION 13.31 • n=7 Participants
|
40.25 years
STANDARD_DEVIATION 13.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
68 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 38Population: Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=87 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=87 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38
|
26.4 percentage of subjects
|
21.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 38Population: Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =\< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=87 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=87 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Percentage of Subjects With Continuous Remission Off Steroids at Week 38
|
16.1 percentage of subjects
|
14.9 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 38Population: Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI\>150) at Week 0
A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) \> 150 and an increase in CDAI of \>= 70 points versus Week 0. \[The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.\]
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=87 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=85 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
|
57.5 percentage of subjects
|
56.5 percentage of subjects
|
SECONDARY outcome
Timeframe: During the 38-week double-blind treatment periodPopulation: Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI\>150) at Week 0
A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) \> 150 and an increase in CDAI of \>= 70 points versus Week 0. \[The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.\]
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=87 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=85 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
|
83.5 days
Standard Deviation 61.8
|
81.9 days
Standard Deviation 70.4
|
SECONDARY outcome
Timeframe: Over the 38-week double-blind treatment periodPopulation: 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.
The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=87 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=86 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
|
88.66 mg per week
Standard Deviation 38.72
|
122.47 mg per week
Standard Deviation 210.15
|
SECONDARY outcome
Timeframe: Over the 48-week study periodPopulation: 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.
The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=87 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=86 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
|
792.68 mg
Standard Deviation 438.14
|
1294.96 mg
Standard Deviation 4459.27
|
SECONDARY outcome
Timeframe: 6-week run-in period, 38-week double-blind treatment periodPopulation: Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 86 in each group had available values at the 6-week run-in period and over the 38-week double-blind treatment period.
The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=86 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=86 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
|
-111.20 mg per week
Standard Deviation 64.60
|
-78.04 mg per week
Standard Deviation 202.55
|
SECONDARY outcome
Timeframe: Week 38Population: Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively are included in the summary of the Week 38, based on the intention-to-treat (ITT) population.
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=27 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=22 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Crohn's Disease Activity Index (CDAI) Score at Week 38
|
78.90 score on a scale
Standard Deviation 65.05
|
73.42 score on a scale
Standard Deviation 61.09
|
SECONDARY outcome
Timeframe: Week 0, Week 38Population: Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively had available values at Baseline and at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=27 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=22 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Change From Baseline in CDAI Score at Week 38
|
-25.50 score on a scale
Standard Deviation 53.48
|
-18.36 score on a scale
Standard Deviation 75.97
|
SECONDARY outcome
Timeframe: Week 38Population: Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 23 and 27 subjects respectively had available values at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.
The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score \>= 170 points.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=27 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=23 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
|
174.7 score on a scale
Standard Deviation 25.7
|
168.6 score on a scale
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: Week 0, Week 38Population: Of the 87 (Placebo) and 87 (Certolizumab Pegol 400 mg) subjects randomized, 23 and 26 subjects respectively had available values at Baseline and Week 38 and are included in the summary based on the intention-to-treat (ITT) population.
The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score \>= 16 points.
Outcome measures
| Measure |
Certolizumab Pegol 400 mg
n=26 Participants
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=23 Participants
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
|
12.6 score on a scale
Standard Deviation 23.2
|
1.5 score on a scale
Standard Deviation 21.5
|
Adverse Events
Certolizumab Pegol 400 mg
Placebo
Serious adverse events
| Measure |
Certolizumab Pegol 400 mg
n=87 participants at risk
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=87 participants at risk
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Cardiac disorders
Bundle Branch Block Left
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/87 • 48-week study period
|
5.7%
5/87 • Number of events 5 • 48-week study period
|
|
Gastrointestinal disorders
Abdominal Hernia
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Gastrointestinal disorders
Colonic Stenosis
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Gastrointestinal disorders
Ileal Stenosis
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
General disorders
Non-Cardiac Chest Pain
|
2.3%
2/87 • Number of events 2 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
General disorders
Granuloma
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Infections and infestations
Pneumonia
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Infections and infestations
Cellulitis
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Infections and infestations
Clostridium Difficile Colitis
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Infections and infestations
Sepsis
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Infections and infestations
Abscess Intestinal
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Infections and infestations
Influenza
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Nervous system disorders
Grand Mal Convulsion
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Nervous system disorders
Syncope
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Psychiatric disorders
Suicidal Ideation
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Vascular disorders
Hypotension
|
0.00%
0/87 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
Other adverse events
| Measure |
Certolizumab Pegol 400 mg
n=87 participants at risk
Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
Placebo
n=87 participants at risk
Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
|
|---|---|---|
|
Gastrointestinal disorders
Crohn's Disease
|
40.2%
35/87 • Number of events 35 • 48-week study period
|
44.8%
39/87 • Number of events 40 • 48-week study period
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.2%
8/87 • Number of events 10 • 48-week study period
|
12.6%
11/87 • Number of events 14 • 48-week study period
|
|
Gastrointestinal disorders
Nausea
|
10.3%
9/87 • Number of events 9 • 48-week study period
|
9.2%
8/87 • Number of events 12 • 48-week study period
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
10/87 • Number of events 13 • 48-week study period
|
5.7%
5/87 • Number of events 5 • 48-week study period
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
6/87 • Number of events 6 • 48-week study period
|
4.6%
4/87 • Number of events 5 • 48-week study period
|
|
Gastrointestinal disorders
Abdominal Distension
|
8.0%
7/87 • Number of events 7 • 48-week study period
|
2.3%
2/87 • Number of events 4 • 48-week study period
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
5.7%
5/87 • Number of events 5 • 48-week study period
|
4.6%
4/87 • Number of events 8 • 48-week study period
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
3/87 • Number of events 3 • 48-week study period
|
5.7%
5/87 • Number of events 5 • 48-week study period
|
|
General disorders
Fatigue
|
9.2%
8/87 • Number of events 9 • 48-week study period
|
8.0%
7/87 • Number of events 9 • 48-week study period
|
|
General disorders
Pyrexia
|
5.7%
5/87 • Number of events 6 • 48-week study period
|
8.0%
7/87 • Number of events 8 • 48-week study period
|
|
General disorders
Injection Site Reaction
|
6.9%
6/87 • Number of events 9 • 48-week study period
|
1.1%
1/87 • Number of events 1 • 48-week study period
|
|
Infections and infestations
Nasopharyngitis
|
13.8%
12/87 • Number of events 14 • 48-week study period
|
14.9%
13/87 • Number of events 15 • 48-week study period
|
|
Infections and infestations
Urinary Tract Infection
|
8.0%
7/87 • Number of events 11 • 48-week study period
|
9.2%
8/87 • Number of events 10 • 48-week study period
|
|
Infections and infestations
Sinusitis
|
5.7%
5/87 • Number of events 6 • 48-week study period
|
9.2%
8/87 • Number of events 8 • 48-week study period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
12/87 • Number of events 15 • 48-week study period
|
10.3%
9/87 • Number of events 10 • 48-week study period
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
10.3%
9/87 • Number of events 13 • 48-week study period
|
5.7%
5/87 • Number of events 5 • 48-week study period
|
|
Nervous system disorders
Headache
|
21.8%
19/87 • Number of events 47 • 48-week study period
|
14.9%
13/87 • Number of events 23 • 48-week study period
|
|
Renal and urinary disorders
Haematuria
|
5.7%
5/87 • Number of events 5 • 48-week study period
|
0.00%
0/87 • 48-week study period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
6/87 • Number of events 7 • 48-week study period
|
3.4%
3/87 • Number of events 3 • 48-week study period
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.6%
4/87 • Number of events 6 • 48-week study period
|
6.9%
6/87 • Number of events 7 • 48-week study period
|
Additional Information
Study Director
UCB Clinical Trial Call Center
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER