Assessing the Use of Certolizumab Pegol in Adult Subjects... | NCT00993668

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo	Other: Placebo
Cimzia	Experimental	Certolizumab pegol	Biological: Certolizumab pegol

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	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).

Measure	Description	Time Frame
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.		Baseline, End of single blind period (Week 6)
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.		Baseline, End of single blind period (Week 6)

Measure	Description	Time Frame
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.		End of single blind period (Week 6)
Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be at least 18 years old at the screening visit
Subjects must be able to understand the information provided to them and to give written informed consent, and be able and willing to comply with the study requirements
Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and spermicide. Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 10 weeks after the last dose of CZP. Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for 10 weeks after the subject receives their last dose of CZP
Subjects must have a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 6-months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria
Subjects must have active RA disease as defined by: ≥ 4 tender joints (28 joint count) at Screening and Week 0; and ≥ 4 swollen joints (28 joint count) at Screening and Week 0

Exclusion Criteria:

Subjects who have a diagnosis of any other inflammatory arthritis (eg., psoriatic arthritis or ankylosing spondylitis)
Subjects who have a history of an infected joint prosthesis at any time with that prosthesis still in situ
Subjects must be free of defined prohibited medication and biological therapy
Subjects who have received any experimental nonbiological therapy, within or outside of a clinical trial in the 3 months prior to Week 0
Subjects who have received any experimental biological agent in the past 3 months or within 5 half-lives prior to Week 0 (whichever is longer)
Subjects who have received previous treatment with biological response modifier therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.
Subjects with a history of pneumococcal or influenza infection in the last 3 months
Subjects with a history of pneumococcal vaccination in the last 5 years
Subjects with a history of influenza vaccination within the last 6 months
Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the trial or within 3 months following last dose of study drug
Subjects with a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life-threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection
Subjects who have had a splenectomy
Subjects who have had a hypersensitivity reaction to previous pneumococcal or influenza vaccination
Subjects who have a known hypersensitivity to eggs and egg products or to other components of the vaccine
Subjects with a history of Guillain-Barre syndrome
Subjects with a history of tuberculosis, active tuberculosis, positive chest x-ray for tuberculosis, or positive purified protein derivative (PPD) skin test (defined as induration of ≥5 mm). Subjects who are not candidates for PPD testing due to prior severe reaction to the PPD test or a history of PPD positivity must undergo an Elispot test instead for tuberculosis evaluation. Subjects testing positive via the PPD or having an indeterminate or positive Elispot test, or for which latent tuberculosis cannot be ruled out, may be enrolled in the study provided that they are treated (eg., isoniazid for 9 months) and that their treatment has been initiated at least 4 weeks prior to the first administration of CZP
Subjects at high risk of infection (eg., presence of leg ulcers or an indwelling urinary catheter, persistent or recurrent chest infections, bedridden or wheelchair bound subjects)
Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease
Subjects with known concurrent acute or chronic viral hepatitis B or C or positive hepatitis B surface antigen (HBs-Ag) or hepatitis C virus antibody (HCV-Ab)
Subjects with known human immunodeficiency virus (HIV) infection
Subjects receiving any live or attenuated vaccination within 12 weeks prior to Week 0
Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than 5 years prior to screening)
Subjects with Class III or Class IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria
Subjects with a history of, or suspected, demyelinating disease of the central nervous system (eg., multiple sclerosis or optic neuritis)
Subjects with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
Subjects with any other condition (eg., clinically significant laboratory values) which in the Investigator's judgement would make the subject unsuitable for inclusion in the study
Subjects with a history of an adverse reaction to polyethylene glycol (PEG)

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1-877-822-9493 (UCB)	Study Director

PubMed Identifier	Type	Citation	Retractions
24584918	Derived	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.

Label	URL
FDA Safety Alerts and Recalls	View source

ID	Title	Description
FG000	Placebo	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).
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants	OG00088 OG00188

Title

Denominators

Categories

Title	Measurements
	OG00062.5(52.4 to 72.6) OG00154.5(44.1 to 64.9)

Primary

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.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants

Secondary

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.

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.

Posted

Number

95% Confidence Interval

percentage of participants

End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants

Secondary

Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.

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.

Posted

Number

95% Confidence Interval

percentage of participants

End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants	OG000

Secondary

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.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants

Secondary

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.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, End of single blind period (week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants

Secondary

Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.

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.

Posted

Number

95% Confidence Interval

percentage of participants

End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants

Secondary

Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.

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.

Posted

Number

95% Confidence Interval

percentage of participants

End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants	OG000

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, End of single blind period (Week 6)

ID	Title	Description
OG000	Placebo	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).
OG001	Cimzia	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).

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac Failure Congestive	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0022 events2 affected219 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0023 events1 affected219 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Chest Pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0022 events2 affected219 at risk
Pneumonia	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0025 events4 affected219 at risk
Bronchitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Latent Tuberculosis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Gastroenteritis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Cellulitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Chest Wall Abscess	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected110 at risk EG0020 events0 affected219 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected110 at risk EG0021 events1 affected219 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Chordoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Non-systematic Assessment	EG0001 events1 affected114 at risk EG0010 events0 affected110 at risk EG0020 events0 affected219 at risk
Depressed Level Of Consciousness	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Syncope	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected110 at risk EG0021 events1 affected219 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0011 events1 affected110 at risk EG0021 events1 affected219 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Bronchial Hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Pulmonary Granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0010 events0 affected110 at risk EG0021 events1 affected219 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 events6 affected114 at risk EG0017 events6 affected110 at risk EG00222 events20 affected219 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0008 events7 affected114 at risk EG0012 events2 affected110 at risk EG00222 events18 affected219 at risk
Fatigue	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 events5 affected114 at risk EG0012 events2 affected110 at risk EG00220 events18 affected219 at risk
Pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 events4 affected114 at risk EG0014 events4 affected110 at risk EG00215 events11 affected219 at risk
Nasopharyngitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0006 events6 affected114 at risk EG00110 events10 affected110 at risk EG00236 events31 affected219 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0006 events6 affected114 at risk EG0014 events4 affected110 at risk EG00232 events30 affected219 at risk
Sinusitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0005 events5 affected114 at risk EG0012 events2 affected110 at risk EG00228 events23 affected219 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 events0 affected114 at risk EG0014 events4 affected110 at risk EG00217 events17 affected219 at risk
Bronchitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0003 events3 affected114 at risk EG0010 events0 affected110 at risk EG00216 events14 affected219 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 events3 affected114 at risk EG0013 events3 affected110 at risk EG00219 events16 affected219 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 events4 affected114 at risk EG0010 events0 affected110 at risk EG00218 events11 affected219 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 events3 affected114 at risk EG0012 events2 affected110 at risk EG00226 events20 affected219 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0008 events5 affected114 at risk EG0013 events3 affected110 at risk EG00225 events15 affected219 at risk
Headache	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG00023 events15 affected114 at risk EG00112 events8 affected110 at risk EG00271 events28 affected219 at risk
Dizziness	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 events2 affected114 at risk EG0011 events1 affected110 at risk EG00216 events13 affected219 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00010 events9 affected114 at risk EG0012 events2 affected110 at risk EG00226 events23 affected219 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 events2 affected114 at risk EG0014 events4 affected110 at risk EG00218 events18 affected219 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 events2 affected114 at risk EG0014 events4 affected110 at risk EG00215 events14 affected219 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 events1 affected114 at risk EG0015 events4 affected110 at risk EG00218 events15 affected219 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D001172	Arthritis, Rheumatoid
D007251	Influenza, Human

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Placebo	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).
BG001	Cimzia	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).
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo (Single Blind)	Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4	1	114	29	114
EG001	Cimzia (Single Blind)	Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4	2	110	22	110
EG002	Cimzia at Any Time	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).	15	219	155	219