Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

• 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: UCB Pharma
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Placebo	Cimzia	Total
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
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

Outcome Measures

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.
Description	[Not Specified]
Time Frame	Baseline, End of single blind period (Week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	Baseline, End of single blind period (Week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	End of single blind period (Week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	End of single blind period (Week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	Baseline, End of single blind period (Week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	Baseline, End of single blind period (week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	End of single blind period (Week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	End of single blind period (Week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	Baseline, End of single blind period (Week 6)

Outcome Measure Data

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
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.
Description	[Not Specified]
Time Frame	Baseline, End of single blind period (Week 6)

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--		--/--		--/--
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)
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)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB, Inc
• Phone: +1 877 822 9493

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kivitz AJ, Schechtman J, Texter M, Fichtner A, de Longueville M, Chartash EK. Vaccine responses in patients with rheumatoid arthritis treated with certolizumab pegol: results from a single-blind randomized phase IV trial. J Rheumatol. 2014 Apr;41(4):648-57. doi: 10.3899/jrheum.130945. Epub 2014 Mar 1.

• 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