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Trial record 1 of 1 for:    ra0017
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Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

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ClinicalTrials.gov Identifier: NCT00993668
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : June 20, 2011
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Other: Placebo
Biological: Certolizumab pegol
Enrollment 224
Recruitment Details This study started in September of 2009 with recruitment occurring in the United States. The primary outcome completed in June 2010 and the open-label extension completed in February 2011.
Pre-assignment Details Treatment column headings reflect the treatment received in the Single-Blind (SB) period.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32). Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Period Title: Single-Blind Period
Started 114 110
Completed 110 107
Not Completed 4 3
Reason Not Completed
Adverse Event             1             1
Lack of Efficacy             0             1
Lost to Follow-up             3             1
Period Title: Open-Label Period
Started 109 [1] 106 [1]
Completed 86 91
Not Completed 23 15
Reason Not Completed
Adverse Event             9             8
Lack of Efficacy             4             3
Withdrawal by Subject             4             3
Lost to Follow-up             6             1
[1]
1 subject chose not to enter the optional open-label period
Arm/Group Title Placebo Cimzia Total
Hide Arm/Group Description Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32). Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Total of all reporting groups
Overall Number of Baseline Participants 114 110 224
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 110 participants 224 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
102
  89.5%
94
  85.5%
196
  87.5%
>=65 years
12
  10.5%
16
  14.5%
28
  12.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 110 participants 224 participants
52.65  (11.12) 53.05  (11.78) 52.85  (11.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 110 participants 224 participants
Female
87
  76.3%
92
  83.6%
179
  79.9%
Male
27
  23.7%
18
  16.4%
45
  20.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 114 participants 110 participants 224 participants
114 110 224
1.Primary Outcome
Title Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.
Hide Description [Not Specified]
Time Frame Baseline, End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 88 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.5
(52.4 to 72.6)
54.5
(44.1 to 64.9)
2.Primary Outcome
Title Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.
Hide Description [Not Specified]
Time Frame Baseline, End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 83 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.4
(51.0 to 71.9)
53.5
(42.9 to 64.0)
3.Secondary Outcome
Title Percentage of All Subjects Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.
Hide Description [Not Specified]
Time Frame End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.2
(49.0 to 67.4)
53.3
(43.8 to 62.7)
4.Secondary Outcome
Title Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.
Hide Description [Not Specified]
Time Frame End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 109 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 109 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.1
(44.8 to 63.5)
50.5
(41.0 to 59.9)
5.Secondary Outcome
Title Percentage of Subjects With no Previous Protective Pneumococcal Antibody Titers at Baseline With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.
Hide Description [Not Specified]
Time Frame Baseline, End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 180 were in the Per Protocol Set Pneumococcal (PPSP) population (90 Placebo, 90 CZP) without baseline protective titers. Of these 180 subjects 150 (75 Placebo, 75 CZP) had protective pneumococcal antibody titers and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 75 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57.3
(46.1 to 68.5)
50.7
(39.4 to 62.0)
6.Secondary Outcome
Title Percentage of Subjects With no Previous Protective Influenza Antibody Titers at Baseline With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.
Hide Description [Not Specified]
Time Frame Baseline, End of single blind period (week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers but with protective influenza antibody titers, and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 83 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.5
(64.0 to 83.0)
64.0
(53.8 to 74.1)
7.Secondary Outcome
Title Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.
Hide Description [Not Specified]
Time Frame End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 110 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65.5
(56.6 to 74.3)
62.6
(53.4 to 71.8)
8.Secondary Outcome
Title Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.
Hide Description [Not Specified]
Time Frame End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 216 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 109 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.1
(69.2 to 85.0)
71.0
(62.4 to 79.6)
9.Secondary Outcome
Title Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens at Week 6 by Concomitant Methotrexate (MTX) Use.
Hide Description [Not Specified]
Time Frame Baseline, End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 88 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Concomitant MTX Use (n=60, 63)
50.0
(37.3 to 62.7)
44.4
(32.2 to 56.7)
No Concomitant MTX Use (n=28, 25)
89.3
(77.8 to 100.00)
80.0
(64.3 to 95.7)
10.Secondary Outcome
Title Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens at Week 6 by Concomitant MTX Use.
Hide Description [Not Specified]
Time Frame Baseline, End of single blind period (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.
Arm/Group Title Placebo Cimzia
Hide Arm/Group Description:
Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
Overall Number of Participants Analyzed 83 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Concomitant MTX Use (n=57, 59)
50.9
(37.9 to 63.9)
45.8
(33.1 to 58.5)
No Concomitant MTX Use (n=26, 27)
84.6
(70.7 to 98.5)
70.4
(53.1 to 87.6)
Time Frame Adverse Event (AE) data summarized in the first two columns refer to the 6-week Single-Blind (SB) period of the study. The final column refers to AE data collected on subjects who received Cimzia at any time during the study (up to 42 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Single Blind) Cimzia (Single Blind) Cimzia at Any Time
Hide Arm/Group Description Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 Certolizumab pegol (at any time) - Subjects randomized to receive Certolizumab pegol (CZP) during the single blind (SB) period will receive two subcutaneous (sc) injections of SB CZP 200 mg at Weeks 0, 2, and 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Subjects randomized to placebo during the SB period will receive two 0.9% saline sc injections at Week 0, Week 2, and Week 4, followed by two sc injections of OL CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
All-Cause Mortality
Placebo (Single Blind) Cimzia (Single Blind) Cimzia at Any Time
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo (Single Blind) Cimzia (Single Blind) Cimzia at Any Time
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/114 (0.88%)      2/110 (1.82%)      15/219 (6.85%)    
Cardiac disorders       
Cardiac Failure Congestive * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 2/219 (0.91%)  2
Cardiogenic Shock * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Atrial Fibrillation * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  3
Myocardial Infarction * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Gastrointestinal disorders       
Diarrhoea * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Small Intestinal Obstruction * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Abdominal Pain * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Vomiting * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
General disorders       
Chest Pain * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 2/219 (0.91%)  2
Infections and infestations       
Pneumonia * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 4/219 (1.83%)  5
Bronchitis * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Latent Tuberculosis * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Pulmonary Tuberculosis * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Gastroenteritis * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Cellulitis * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Chest Wall Abscess * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Musculoskeletal and connective tissue disorders       
Intervertebral Disc Protrusion * 1  1/114 (0.88%)  1 0/110 (0.00%)  0 0/219 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder Cancer * 1  0/114 (0.00%)  0 1/110 (0.91%)  1 1/219 (0.46%)  1
Squamous Cell Carcinoma * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Chordoma * 1  1/114 (0.88%)  1 0/110 (0.00%)  0 0/219 (0.00%)  0
Nervous system disorders       
Depressed Level Of Consciousness * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Syncope * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Carotid Artery Stenosis * 1  0/114 (0.00%)  0 1/110 (0.91%)  1 1/219 (0.46%)  1
Transient Ischaemic Attack * 1  0/114 (0.00%)  0 1/110 (0.91%)  1 1/219 (0.46%)  1
Reproductive system and breast disorders       
Endometriosis * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Respiratory, thoracic and mediastinal disorders       
Bronchial Hyperreactivity * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Chronic Obstructive Pulmonary Disease * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Pulmonary Granuloma * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Acute Respiratory Failure * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
Skin and subcutaneous tissue disorders       
Acne * 1  0/114 (0.00%)  0 0/110 (0.00%)  0 1/219 (0.46%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Single Blind) Cimzia (Single Blind) Cimzia at Any Time
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/114 (25.44%)      22/110 (20.00%)      155/219 (70.78%)    
Gastrointestinal disorders       
Nausea * 1  6/114 (5.26%)  6 6/110 (5.45%)  7 20/219 (9.13%)  22
Diarrhoea * 1  7/114 (6.14%)  8 2/110 (1.82%)  2 18/219 (8.22%)  22
General disorders       
Fatigue * 1  5/114 (4.39%)  5 2/110 (1.82%)  2 18/219 (8.22%)  20
Pain * 1  4/114 (3.51%)  7 4/110 (3.64%)  4 11/219 (5.02%)  15
Infections and infestations       
Nasopharyngitis * 1  6/114 (5.26%)  6 10/110 (9.09%)  10 31/219 (14.16%)  36
Upper Respiratory Tract Infection * 1  6/114 (5.26%)  6 4/110 (3.64%)  4 30/219 (13.70%)  32
Sinusitis * 1  5/114 (4.39%)  5 2/110 (1.82%)  2 23/219 (10.50%)  28
Urinary Tract Infection * 1  0/114 (0.00%)  0 4/110 (3.64%)  4 17/219 (7.76%)  17
Bronchitis * 1  3/114 (2.63%)  3 0/110 (0.00%)  0 14/219 (6.39%)  16
Musculoskeletal and connective tissue disorders       
Back Pain * 1  3/114 (2.63%)  3 3/110 (2.73%)  3 16/219 (7.31%)  19
Pain In Extremity * 1  4/114 (3.51%)  6 0/110 (0.00%)  0 11/219 (5.02%)  18
Rheumatoid Arthritis * 1  3/114 (2.63%)  3 2/110 (1.82%)  2 20/219 (9.13%)  26
Arthralgia * 1  5/114 (4.39%)  8 3/110 (2.73%)  3 15/219 (6.85%)  25
Nervous system disorders       
Headache * 1  15/114 (13.16%)  23 8/110 (7.27%)  12 28/219 (12.79%)  71
Dizziness * 1  2/114 (1.75%)  2 1/110 (0.91%)  1 13/219 (5.94%)  16
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal Pain * 1  9/114 (7.89%)  10 2/110 (1.82%)  2 23/219 (10.50%)  26
Cough * 1  2/114 (1.75%)  2 4/110 (3.64%)  4 18/219 (8.22%)  18
Sinus Congestion * 1  2/114 (1.75%)  2 4/110 (3.64%)  4 14/219 (6.39%)  15
Skin and subcutaneous tissue disorders       
Rash * 1  1/114 (0.88%)  1 4/110 (3.64%)  5 15/219 (6.85%)  18
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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: UCB Clinical Trial Call Center
Organization: UCB, Inc
Phone: +1 877 822 9493
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00993668    
Other Study ID Numbers: RA0017
First Submitted: October 9, 2009
First Posted: October 12, 2009
Results First Submitted: May 23, 2011
Results First Posted: June 20, 2011
Last Update Posted: August 1, 2018