Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (REALISTIC)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00717236

First received: July 15, 2008

Last updated: March 2, 2012

Last verified: March 2012

History of Changes

Results First Received: March 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Interventions:	Drug: Certolizumab pegol (CZP) Other: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study started in July 2008 with subjects from the United States, Canada, France, Germany, Italy, the Netherlands, and Spain. The primary completion date occurred in March 2010, with study completion in March 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1648 subjects that were screened, 585 subjects had screen failures. Therefore, 1063 subjects were randomized in this study.

Reporting Groups

	Description
Certolizumab Pegol (CZP)	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.

Participant Flow for 2 periods

Period 1: Double-Blind Period

	Certolizumab Pegol (CZP)	Placebo
STARTED	851	212
COMPLETED	771	184
NOT COMPLETED	80	28
Adverse Event	33	6
Lack of Efficacy	6	6
Lost to Follow-up	3	5
Withdrawal by Subject	10	2
Loss of efficacy	3	0
Other: Death	1	0
Other: Pregnancy	1	0
Other: Protocol Violation	2	0
Other: Inclusion/Exclusion criteria	6	2
Other: Site withdrew	2	0
Other: Screening failure	1	0
Other: subject withdrew consent	1	1
Other: Abnormal chest X-ray	2	1
Other: History of adenoid grown	1	0
Other: History of cancer	1	0
Other: Sponsor request	1	0
Other: Inappropriate randomization	1	0
Other: Detection of Hepatitis C Virus	1	0
Other: Subject moved	1	1
Other: Stopped taking DMARD	1	0
Other: Prohibited medication taken	2	2
Other: Transportation problems	0	1
Other: Investigator Decision	0	1

Period 2: Open-Label Period

	Certolizumab Pegol (CZP)	Placebo
STARTED	771	184
COMPLETED	646	163
NOT COMPLETED	125	21
Adverse Event	29	4
Lack of Efficacy	30	8
Lost to Follow-up	28	4
Withdrawal by Subject	20	2
Loss of Efficacy	6	1
Other: Peripheral Neuropathy	0	1
Other: Lack of Compliance	1	1
Other: History of Basal Cell Carcinoma	1	0
Other: Moved	1	0
Other: Investigator Decision	1	0
Other: Loss of Staff (unblinded)	1	0
Other: Sponsor Request	3	0
Other: Cataract Surgery	1	0
Other: Administration of Golimumab	1	0
Other: Completion Accidently Performed	1	0
Other: Medical Monitor Recommendation	1	0

Baseline Characteristics

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Reporting Groups

	Description
Certolizumab Pegol (CZP)	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Total	Total of all reporting groups

Baseline Measures

	Certolizumab Pegol (CZP)	Placebo	Total
Number of Participants [units: participants]	851	212	1063
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	644	164	808
>=65 years	207	48	255
Age [units: years] Mean ± Standard Deviation	55.4 ± 12.43	53.9 ± 12.66	55.1 ± 12.49
Gender [units: participants]
Female	660	169	829
Male	191	43	234
Region of Enrollment [units: participants]
France	14	0	14
United States	575	141	716
Canada	65	17	82
Spain	26	8	34
Netherlands	4	0	4
Germany	154	44	198
Italy	13	2	15

Outcome Measures

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1. Primary:

American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 1

2. Secondary:

American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use. [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 2

3. Secondary:

American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use. [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 3

4. Secondary:

American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 4

5. Secondary:

American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use [ Time Frame: Baseline, Week 12 ]

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6. Secondary:

American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 6

7. Secondary:

American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years. [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 7

8. Secondary:

American College of Rheumatology 50% (ACR50) Response at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 8

9. Secondary:

American College of Rheumatology 70% (ACR70) Response at Week 12. [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 9

10. Secondary:

Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 10

11. Secondary:

Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 [ Time Frame: Baseline, Week 12 ]

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13. Secondary:

DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12 [ Time Frame: Week 12 ]

Show Outcome Measure 13

14. Secondary:

SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12 [ Time Frame: Week 12 ]

Show Outcome Measure 14

15. Secondary:

CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12 [ Time Frame: Week 12 ]

Show Outcome Measure 15

16. Secondary:

Change From Baseline in Tender Joint Count (TJC) at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 16

17. Secondary:

Change From Baseline in Swollen Joint Count (SJC) at Week 12 [ Time Frame: Baseline, Week 12 ]

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18. Secondary:

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 18

19. Secondary:

Change From Baseline in C-reactive Protein (CRP) at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 19

20. Secondary:

Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 20

21. Secondary:

Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 21

22. Secondary:

Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 22

23. Secondary:

Time to Sustained American College of Rheumatology 20% (ACR20) Response [ Time Frame: Baseline up to Week 12 ]

Show Outcome Measure 23

24. Secondary:

European League Against Rheumatism (EULAR) Response at Week 12 [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 24

25. Secondary:

American College of Rheumatology 20% (ACR20) Response at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 25

26. Secondary:

American College of Rheumatology 50% (ACR50) Response at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 26

27. Secondary:

American College of Rheumatology 70% (ACR70) Response at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 27

28. Secondary:

Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 28

29. Secondary:

Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 29

30. Secondary:

Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 30

31. Secondary:

DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28 [ Time Frame: Week 28 ]

Show Outcome Measure 31

32. Secondary:

SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28 [ Time Frame: Week 28 ]

Show Outcome Measure 32

33. Secondary:

CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28 [ Time Frame: Week 28 ]

Show Outcome Measure 33

34. Secondary:

Change From Baseline in Tender Joint Count (TJC) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 34

35. Secondary:

Change From Baseline in Swollen Joint Count (SJC) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 35

36. Secondary:

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 36

37. Secondary:

Change From Baseline in C-reactive Protein (CRP) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 37

38. Secondary:

Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 38

39. Secondary:

Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 39

40. Secondary:

Change From Baseline in Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28 [ Time Frame: Baseline, Week 28 ]

Show Outcome Measure 40

Serious Adverse Events

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Time Frame	The first two columns refer to the 12-week double blind phase, and an additional 12-week follow up for those who withdrew during the double blind period. The third column displays AEs for the 56-week open label phase and the 12-week safety follow-up.
Additional Description	Of the 1063 subjects in the Full Analysis Set (FAS), 1055 are included in the adverse event reporting based upon the Safety Set (SS) population. The Safety Set includes all subjects randomized who received at least 1 dosing.

Reporting Groups

	Description
Certolizumab Pegol (CZP)	400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo	Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg certolizumab pegol (CZP) given as 1 subcutaneous injection every other week for a minimum 16 additional weeks until CZP is commercially available.
Open Label Certolizumab Pegol (CZP)	Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.

Serious Adverse Events

	Certolizumab Pegol (CZP)	Placebo	Open Label Certolizumab Pegol (CZP)
Total, serious adverse events
# participants affected / at risk	52/846 (6.15%)	12/209 (5.74%)	77/954 (8.07%)
Blood and lymphatic system disorders
Anaemia ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	0/954 (0.00%)
# events	0	1	0
Lymphadenopathy ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Cardiac disorders
Coronary artery disease ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Cardiac failure ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	1/954 (0.10%)
# events	1	0	1
Acute myocardial infarction ^{* 1}
# participants affected / at risk	2/846 (0.24%)	0/209 (0.00%)	2/954 (0.21%)
# events	2	0	2
Arteriospasm coronary ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Myocardial infarction ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	3/954 (0.31%)
# events	1	0	3
Artial fibrillation ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	2/954 (0.21%)
# events	1	0	3
Cardiac failure congestive ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	3/954 (0.31%)
# events	0	0	3
Perocardial effusion ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Supraventricular tachycardia ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Angina Pectoris ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Ear and labyrinth disorders
Vertigo ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Ear pain ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Gastrointestinal disorders
Pancreatitis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Abdominal pain ^{* 1}
# participants affected / at risk	2/846 (0.24%)	0/209 (0.00%)	0/954 (0.00%)
# events	2	0	0
Nausea ^{* 1}
# participants affected / at risk	1/846 (0.12%)	1/209 (0.48%)	0/954 (0.00%)
# events	1	1	0
Vomiting ^{* 1}
# participants affected / at risk	2/846 (0.24%)	0/209 (0.00%)	0/954 (0.00%)
# events	2	0	0
Umbilical hernia ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Gastrooesophageal reflux disease ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Colitis ischaemic ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Diarrhoea ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	2
Impaired gastric emptying ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Large intestine perforation ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Volvulus ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Stomatitis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
General disorders
Chest pain ^{* 1}
# participants affected / at risk	3/846 (0.35%)	2/209 (0.96%)	1/954 (0.10%)
# events	3	2	1
Non-cardiac chest pain ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Impaired healing ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Necrosis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Hepatobiliary disorders
Cholecystitis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Immune system disorders
Drug hypersensitivity ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Infections and infestations
Diverticulitis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	2/954 (0.21%)
# events	1	0	2
Bronchopulmonary aspergillosis ^{* 1}
# participants affected / at risk	2/846 (0.24%)	0/209 (0.00%)	0/954 (0.00%)
# events	3	0	0
Cellulitis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	5/954 (0.52%)
# events	1	0	5
Bursitis infective ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Osteomyelitis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Abscess limb ^{* 1}
# participants affected / at risk	2/846 (0.24%)	0/209 (0.00%)	0/954 (0.00%)
# events	2	0	0
Bronchitis ^{* 1}
# participants affected / at risk	2/846 (0.24%)	0/209 (0.00%)	3/954 (0.31%)
# events	2	0	4
Pneumonia ^{* 1}
# participants affected / at risk	4/846 (0.47%)	1/209 (0.48%)	8/954 (0.84%)
# events	4	1	8
Pneumonia necrotising ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Urosepsis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Staphylococcal infection ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Pharyngitis streptococcal ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	1/954 (0.10%)
# events	0	1	1
Upper respiratory tract infection ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Cystitis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	0/954 (0.00%)
# events	0	1	0
Pyelonephritis acute ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Urinary tract infection ^{* 1}
# participants affected / at risk	3/846 (0.35%)	0/209 (0.00%)	3/954 (0.31%)
# events	3	0	3
Gastroenteritis viral ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Pyelonephritis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	1/209 (0.48%)	0/954 (0.00%)
# events	1	1	0
Clostridial infection ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Gastroenteritis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Ear lobe infection ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Postoperative wound infection ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Pneumonia streptococcal ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Disseminated tuberculosis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Sinusitis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	2
Gastritis viral ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Injury, poisoning and procedural complications
Femoral neck fracture ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	0/954 (0.00%)
# events	0	1	0
Hip fracture ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Lower limb fracture ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	0/954 (0.00%)
# events	0	1	0
Tibia fracture ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Foreign body trauma ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Spinal compression fracture ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Concussion ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Subdural haematoma ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Device breakage ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Gastrointestinal disorder postoperative ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Ankle fracture ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Polytraumatism ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Skin laceration ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Upper limb fracture ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Investigations
Blood glucose increased ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	1/954 (0.10%)
# events	1	0	1
Metabolism and nutrition disorders
Dehydration ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	3/954 (0.31%)
# events	1	0	3
Diabetes mellitus ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	0/954 (0.00%)
# events	0	1	0
Hyponatraemia ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	3/954 (0.31%)
# events	1	0	3
Spinal column stenosis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Bursitis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Intervertebral disc protrusion ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	2
Rotator cuff syndrome ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Arthralgia ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Osteoarthritis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	1/954 (0.10%)
# events	0	1	1
Carcinoid tumour ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Hepatic neoplasm ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	0/954 (0.00%)
# events	0	1	0
Adenocarcinoma pancreas ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Malignant melanoma ^{* 1}
# participants affected / at risk	1/846 (0.12%)	1/209 (0.48%)	1/954 (0.10%)
# events	1	1	1
Sarcoma uterus ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Colon adenoma ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Breast cancer metastatic ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Ovarian granulosa-theca cell tumor ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Mycosis fungoides ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Small cell lung cancer metastatic ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	2
Basal cell carcinoma ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Uterine leiomyoma ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Nervous system disorders
Syncope ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	2/954 (0.21%)
# events	1	0	2
Brain stem infarction ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Grand mal convulsion ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Dizziness ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Pregnancy, puerperium and perinatal conditions
Pregnancy ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	1/954 (0.10%)
# events	1	0	1
Psychiatric disorders
Suicide attempt ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Depression ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Renal and urinary disorders
Bladder prolapse ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Azotaemia ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Renal failure ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	2
Renal failure acute ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Renal impairment ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Nephrolithiasis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Reproductive system and breast disorders
Cervical dysplasia ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional ^{* 1}
# participants affected / at risk	0/846 (0.00%)	1/209 (0.48%)	1/954 (0.10%)
# events	0	1	1
Asthma ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	1/954 (0.10%)
# events	1	0	1
Chronic obstructive pulmonary disease ^{* 1}
# participants affected / at risk	2/846 (0.24%)	0/209 (0.00%)	0/954 (0.00%)
# events	2	0	0
Pulmonary oedema ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Dyspnoea ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	1/954 (0.10%)
# events	1	0	1
Pneumonitis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Plural effusion ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Pulmonary embolism ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	2
Skin and subcutaneous tissue disorders
Angioneurotic oedema ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Urticaria ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Drug eurption ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Skin ulcer ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Surgical and medical procedures
Gastric bypass ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Synoviorthesis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Vascular disorders
Hypertensive crisis ^{* 1}
# participants affected / at risk	1/846 (0.12%)	0/209 (0.00%)	0/954 (0.00%)
# events	1	0	0
Peripheral artery aneurysm ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Deep vein thrombosis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	2
Femoral arterial stenosis ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	1/954 (0.10%)
# events	0	0	1
Hypertension ^{* 1}
# participants affected / at risk	0/846 (0.00%)	0/209 (0.00%)	2/954 (0.21%)
# events	0	0	3

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (9.0)

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: UCB has > 60 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 the results shall be published regardless of outcome.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493

No publications provided by UCB, Inc.

Publications automatically indexed to this study:

Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00717236 History of Changes
Other Study ID Numbers:	C87094, 2008-005427-28
Study First Received:	July 15, 2008
Results First Received:	March 10, 2011
Last Updated:	March 2, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Netherlands: Medicines Evaluation Board (MEB) Spain: Spanish Agency of Medicines

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