Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease (COSPAR1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00349752
Recruitment Status : Terminated (Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited)
First Posted : July 10, 2006
Results First Posted : December 1, 2010
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Biological: certolizumab pegol 400 mg
Other: Placebo
Enrollment 174
Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description 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 provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
Period Title: Overall Study
Started 87 87
Completed 28 23
Not Completed 59 64
Reason Not Completed
Adverse Event             8             12
Lack of Efficacy             37             42
Lost to Follow-up             4             2
Personal reasons             6             5
Other: Required exclusionary medication             0             1
Other: Non compliance             0             1
Other: Patient stopped steroids             0             1
Other: Patient's steroid use             1             0
Other: Ineligible             1             0
Other: Inadvertently unblinded             1             0
Other:History of squamous cell carcinoma             1             0
Arm/Group Title Certolizumab Pegol 400 mg Placebo Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 87 87 174
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 87 participants 174 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
85
  97.7%
85
  97.7%
170
  97.7%
>=65 years
2
   2.3%
2
   2.3%
4
   2.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 87 participants 174 participants
40.77  (13.20) 39.73  (13.31) 40.25  (13.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 87 participants 174 participants
Female
52
  59.8%
45
  51.7%
97
  55.7%
Male
35
  40.2%
42
  48.3%
77
  44.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants 87 participants 174 participants
United States 65 68 133
Canada 18 11 29
Germany 4 8 12
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 87 87
Measure Type: Number
Unit of Measure: percentage of subjects
26.4 21.8
2.Secondary Outcome
Title Percentage of Subjects With Continuous Remission Off Steroids at Week 38
Hide Description 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.
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 87 87
Measure Type: Number
Unit of Measure: percentage of subjects
16.1 14.9
3.Secondary Outcome
Title Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
Hide Description 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.]
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 87 85
Measure Type: Number
Unit of Measure: percentage of subjects
57.5 56.5
4.Secondary Outcome
Title Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
Hide Description 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.]
Time Frame During the 38-week double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 87 85
Mean (Standard Deviation)
Unit of Measure: days
83.5  (61.8) 81.9  (70.4)
5.Secondary Outcome
Title Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
Hide Description 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.
Time Frame Over the 38-week double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 87 86
Mean (Standard Deviation)
Unit of Measure: mg per week
88.66  (38.72) 122.47  (210.15)
6.Secondary Outcome
Title Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
Hide Description 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.
Time Frame Over the 48-week study period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 87 86
Mean (Standard Deviation)
Unit of Measure: mg
792.68  (438.14) 1294.96  (4459.27)
7.Secondary Outcome
Title Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
Hide Description 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.
Time Frame 6-week run-in period, 38-week double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: mg per week
-111.20  (64.60) -78.04  (202.55)
8.Secondary Outcome
Title Crohn's Disease Activity Index (CDAI) Score at Week 38
Hide Description 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.
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
78.90  (65.05) 73.42  (61.09)
9.Secondary Outcome
Title Change From Baseline in CDAI Score at Week 38
Hide Description 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.
Time Frame Week 0, Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: score on a scale
-25.50  (53.48) -18.36  (75.97)
10.Secondary Outcome
Title Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Hide Description 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.
Time Frame Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 27 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
174.7  (25.7) 168.6  (23.4)
11.Secondary Outcome
Title Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Hide Description 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.
Time Frame Week 0, Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 26 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
12.6  (23.2) 1.5  (21.5)
Time Frame 48-week study period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Certolizumab Pegol 400 mg Placebo
Hide Arm/Group Description 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 provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
All-Cause Mortality
Certolizumab Pegol 400 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Certolizumab Pegol 400 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/87 (10.34%)      8/87 (9.20%)    
Cardiac disorders     
Bundle Branch Block Left * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Gastrointestinal disorders     
Crohn's Disease * 1  0/87 (0.00%)  0 5/87 (5.75%)  5
Abdominal Hernia * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Upper Gastrointestinal Haemorrhage * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Colonic Stenosis * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Ileal Stenosis * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Intestinal Obstruction * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Intestinal Perforation * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Small Intestinal Obstruction * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Volvulus * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
General disorders     
Non-Cardiac Chest Pain * 1  2/87 (2.30%)  2 0/87 (0.00%)  0
Granuloma * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Infections and infestations     
Pneumonia * 1  1/87 (1.15%)  1 1/87 (1.15%)  1
Cellulitis * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Clostridium Difficile Colitis * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Sepsis * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Abscess Intestinal * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Gastroenteritis Viral * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Influenza * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Injury, poisoning and procedural complications     
Ankle Fracture * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Postoperative Ileus * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Metabolism and nutrition disorders     
Hypokalaemia * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Nervous system disorders     
Grand Mal Convulsion * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Syncope * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Psychiatric disorders     
Suicidal Ideation * 1  1/87 (1.15%)  1 0/87 (0.00%)  0
Renal and urinary disorders     
Renal Failure Acute * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Respiratory Distress * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
Vascular disorders     
Hypotension * 1  0/87 (0.00%)  0 1/87 (1.15%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol 400 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/87 (80.46%)      73/87 (83.91%)    
Gastrointestinal disorders     
Crohn's Disease * 1  35/87 (40.23%)  35 39/87 (44.83%)  40
Abdominal Pain * 1  8/87 (9.20%)  10 11/87 (12.64%)  14
Nausea * 1  9/87 (10.34%)  9 8/87 (9.20%)  12
Vomiting * 1  10/87 (11.49%)  13 5/87 (5.75%)  5
Dyspepsia * 1  6/87 (6.90%)  6 4/87 (4.60%)  5
Abdominal Distension * 1  7/87 (8.05%)  7 2/87 (2.30%)  4
Abdominal Pain Lower * 1  5/87 (5.75%)  5 4/87 (4.60%)  8
Flatulence * 1  3/87 (3.45%)  3 5/87 (5.75%)  5
General disorders     
Fatigue * 1  8/87 (9.20%)  9 7/87 (8.05%)  9
Pyrexia * 1  5/87 (5.75%)  6 7/87 (8.05%)  8
Injection Site Reaction * 1  6/87 (6.90%)  9 1/87 (1.15%)  1
Infections and infestations     
Nasopharyngitis * 1  12/87 (13.79%)  14 13/87 (14.94%)  15
Urinary Tract Infection * 1  7/87 (8.05%)  11 8/87 (9.20%)  10
Sinusitis * 1  5/87 (5.75%)  6 8/87 (9.20%)  8
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  12/87 (13.79%)  15 9/87 (10.34%)  10
Muscle Spasms * 1  9/87 (10.34%)  13 5/87 (5.75%)  5
Nervous system disorders     
Headache * 1  19/87 (21.84%)  47 13/87 (14.94%)  23
Renal and urinary disorders     
Haematuria * 1  5/87 (5.75%)  5 0/87 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  6/87 (6.90%)  7 3/87 (3.45%)  3
Skin and subcutaneous tissue disorders     
Rash * 1  4/87 (4.60%)  6 6/87 (6.90%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for the 174 subjects already recruited. Results should be treated with caution due to the early termination of this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00349752    
Other Study ID Numbers: C87059
2006-003870-88 ( EudraCT Number )
First Submitted: June 30, 2006
First Posted: July 10, 2006
Results First Submitted: July 1, 2010
Results First Posted: December 1, 2010
Last Update Posted: August 9, 2018