Trial Outcomes & Findings for Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines (NCT NCT00993668)

NCT ID: NCT00993668

Last Updated: 2018-08-01

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

224 participants

Primary outcome timeframe

Baseline, End of single blind period (Week 6)

Results posted on

2018-08-01

Participant Flow

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.

Treatment column headings reflect the treatment received in the Single-Blind (SB) period.

Participant milestones

Participant milestones
Measure	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).	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).
Single-Blind Period STARTED	114	110
Single-Blind Period COMPLETED	110	107
Single-Blind Period NOT COMPLETED	4	3
Open-Label Period STARTED	109	106
Open-Label Period COMPLETED	86	91
Open-Label Period NOT COMPLETED	23	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Single-Blind Period Adverse Event	1	1
Single-Blind Period Lack of Efficacy	0	1
Single-Blind Period Lost to Follow-up	3	1
Open-Label Period Adverse Event	9	8
Open-Label Period Lack of Efficacy	4	3
Open-Label Period Withdrawal by Subject	4	3
Open-Label Period Lost to Follow-up	6	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=114 Participants 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).	Cimzia n=110 Participants 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 n=224 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	102 Participants n=99 Participants	94 Participants n=107 Participants	196 Participants n=206 Participants
Age, Categorical >=65 years	12 Participants n=99 Participants	16 Participants n=107 Participants	28 Participants n=206 Participants
Age, Continuous	52.65 years STANDARD_DEVIATION 11.12 • n=99 Participants	53.05 years STANDARD_DEVIATION 11.78 • n=107 Participants	52.85 years STANDARD_DEVIATION 11.42 • n=206 Participants
Sex: Female, Male Female	87 Participants n=99 Participants	92 Participants n=107 Participants	179 Participants n=206 Participants
Sex: Female, Male Male	27 Participants n=99 Participants	18 Participants n=107 Participants	45 Participants n=206 Participants
Region of Enrollment United States	114 participants n=99 Participants	110 participants n=107 Participants	224 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, End of single blind period (Week 6)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants 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).	Cimzia n=88 Participants 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).
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.	62.5 percentage of participants Interval 52.4 to 72.6	54.5 percentage of participants Interval 44.1 to 64.9

PRIMARY outcome

Timeframe: Baseline, End of single blind period (Week 6)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=83 Participants 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).	Cimzia n=86 Participants 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).
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.	61.4 percentage of participants Interval 51.0 to 71.9	53.5 percentage of participants Interval 42.9 to 64.0

SECONDARY outcome

Timeframe: End of single blind period (Week 6)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=110 Participants 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).	Cimzia n=107 Participants 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).
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.	58.2 percentage of participants Interval 49.0 to 67.4	53.3 percentage of participants Interval 43.8 to 62.7

SECONDARY outcome

Timeframe: End of single blind period (Week 6)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=109 Participants 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).	Cimzia n=107 Participants 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).
Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.	54.1 percentage of participants Interval 44.8 to 63.5	50.5 percentage of participants Interval 41.0 to 59.9

SECONDARY outcome

Timeframe: Baseline, End of single blind period (Week 6)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants 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).	Cimzia n=75 Participants 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).
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.	57.3 percentage of participants Interval 46.1 to 68.5	50.7 percentage of participants Interval 39.4 to 62.0

SECONDARY outcome

Timeframe: Baseline, End of single blind period (week 6)

Outcome measures

Outcome measures
Measure	Placebo n=83 Participants 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).	Cimzia n=86 Participants 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).
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.	73.5 percentage of participants Interval 64.0 to 83.0	64.0 percentage of participants Interval 53.8 to 74.1

SECONDARY outcome

Timeframe: End of single blind period (Week 6)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=110 Participants 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).	Cimzia n=107 Participants 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).
Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.	65.5 percentage of participants Interval 56.6 to 74.3	62.6 percentage of participants Interval 53.4 to 71.8

SECONDARY outcome

Timeframe: End of single blind period (Week 6)

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=109 Participants 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).	Cimzia n=107 Participants 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).
Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.	77.1 percentage of participants Interval 69.2 to 85.0	71.0 percentage of participants Interval 62.4 to 79.6

SECONDARY outcome

Timeframe: Baseline, End of single blind period (Week 6)

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants 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).	Cimzia n=88 Participants 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).
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. Concomitant MTX Use (n=60, 63)	50.0 percentage of participants Interval 37.3 to 62.7	44.4 percentage of participants Interval 32.2 to 56.7
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. No Concomitant MTX Use (n=28, 25)	89.3 percentage of participants Interval 77.8 to 100.0	80.0 percentage of participants Interval 64.3 to 95.7

SECONDARY outcome

Timeframe: Baseline, End of single blind period (Week 6)

Outcome measures

Outcome measures
Measure	Placebo n=83 Participants 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).	Cimzia n=86 Participants 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).
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. Concomitant MTX Use (n=57, 59)	50.9 percentage of participants Interval 37.9 to 63.9	45.8 percentage of participants Interval 33.1 to 58.5
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. No Concomitant MTX Use (n=26, 27)	84.6 percentage of participants Interval 70.7 to 98.5	70.4 percentage of participants Interval 53.1 to 87.6

Adverse Events

Placebo (Single Blind)

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Cimzia (Single Blind)

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Cimzia at Any Time

Serious events: 15 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

UCB Clinical Trial Call Center

UCB, Inc

Phone: +1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo (Single Blind) n=114 participants at risk Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4	Cimzia (Single Blind) n=110 participants at risk Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4	Cimzia at Any Time n=219 participants at risk 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).
Gastrointestinal disorders Nausea	5.3% 6/114 • Number of events 6 • 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).	5.5% 6/110 • Number of events 7 • 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).	9.1% 20/219 • Number of events 22 • 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).
Gastrointestinal disorders Diarrhoea	6.1% 7/114 • Number of events 8 • 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).	1.8% 2/110 • Number of events 2 • 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).	8.2% 18/219 • Number of events 22 • 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).
General disorders Fatigue	4.4% 5/114 • Number of events 5 • 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).	1.8% 2/110 • Number of events 2 • 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).	8.2% 18/219 • Number of events 20 • 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).
General disorders Pain	3.5% 4/114 • Number of events 7 • 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).	3.6% 4/110 • Number of events 4 • 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).	5.0% 11/219 • Number of events 15 • 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).
Infections and infestations Nasopharyngitis	5.3% 6/114 • Number of events 6 • 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).	9.1% 10/110 • Number of events 10 • 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).	14.2% 31/219 • Number of events 36 • 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).
Infections and infestations Upper Respiratory Tract Infection	5.3% 6/114 • Number of events 6 • 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).	3.6% 4/110 • Number of events 4 • 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).	13.7% 30/219 • Number of events 32 • 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).
Infections and infestations Sinusitis	4.4% 5/114 • Number of events 5 • 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).	1.8% 2/110 • Number of events 2 • 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).	10.5% 23/219 • Number of events 28 • 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).
Infections and infestations Urinary Tract Infection	0.00% 0/114 • 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).	3.6% 4/110 • Number of events 4 • 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).	7.8% 17/219 • Number of events 17 • 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).
Infections and infestations Bronchitis	2.6% 3/114 • Number of events 3 • 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).	0.00% 0/110 • 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).	6.4% 14/219 • Number of events 16 • 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).
Musculoskeletal and connective tissue disorders Back Pain	2.6% 3/114 • Number of events 3 • 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).	2.7% 3/110 • Number of events 3 • 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).	7.3% 16/219 • Number of events 19 • 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).
Musculoskeletal and connective tissue disorders Pain In Extremity	3.5% 4/114 • Number of events 6 • 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).	0.00% 0/110 • 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).	5.0% 11/219 • Number of events 18 • 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).
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	2.6% 3/114 • Number of events 3 • 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).	1.8% 2/110 • Number of events 2 • 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).	9.1% 20/219 • Number of events 26 • 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).
Musculoskeletal and connective tissue disorders Arthralgia	4.4% 5/114 • Number of events 8 • 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).	2.7% 3/110 • Number of events 3 • 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).	6.8% 15/219 • Number of events 25 • 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).
Nervous system disorders Headache	13.2% 15/114 • Number of events 23 • 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).	7.3% 8/110 • Number of events 12 • 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).	12.8% 28/219 • Number of events 71 • 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).
Nervous system disorders Dizziness	1.8% 2/114 • Number of events 2 • 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).	0.91% 1/110 • Number of events 1 • 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).	5.9% 13/219 • Number of events 16 • 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).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	7.9% 9/114 • Number of events 10 • 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).	1.8% 2/110 • Number of events 2 • 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).	10.5% 23/219 • Number of events 26 • 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).
Respiratory, thoracic and mediastinal disorders Cough	1.8% 2/114 • Number of events 2 • 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).	3.6% 4/110 • Number of events 4 • 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).	8.2% 18/219 • Number of events 18 • 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).
Respiratory, thoracic and mediastinal disorders Sinus Congestion	1.8% 2/114 • Number of events 2 • 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).	3.6% 4/110 • Number of events 4 • 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).	6.4% 14/219 • Number of events 15 • 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).
Skin and subcutaneous tissue disorders Rash	0.88% 1/114 • Number of events 1 • 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).	3.6% 4/110 • Number of events 5 • 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).	6.8% 15/219 • Number of events 18 • 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).