A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of subjects started in June 2005. 121 centers in 22 countries enrolled subjects. Participant Flow refers to the Safety Set consisting of all enrolled subjects who received at least 1 dose of study medication. Of the 857 enrolled subjects, 846 subjects are included in the Safety Set. There was 1 enrolled subject who was never dosed.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consists of 2 populations: of subjects who failed to achieve predefined criteria in preceding study NCT00152386 who entered C87028 on Week 16 of preceding study and of those who completed Week 52 of preceding study. Due to findings of fraud at one site, data of the 10 subjects of the site were not analyzed with data from other sites.

Reporting Groups

Description

Certolizumab Pegol

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Participant Flow:   Overall Study

	Certolizumab Pegol
STARTED	846
COMPLETED	497
NOT COMPLETED	349
Adverse Event	136
Withdrawal by Subject	141
Lost to Follow-up	9
Lack of Efficacy	26
Protocol Violation	15
Other Reason	20
AE & Other	1
Withdrawal by subject & Other	1

Reporting Groups

Description

Certolizumab Pegol

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection. Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Baseline Measures

	Certolizumab Pegol
Number of Participants   [units: participants]	846
Age   [units: participants]
<=18 years	1
Between 18 and 65 years	736
>=65 years	109
Age   [units: years] Mean ( Full Range )	51.5     ( 18 to 81 )
Gender   [units: participants]
Female	701
Male	145
Region of Enrollment   [units: participants]
Serbia	45
United States	56
Estonia	16
Slovakia	45
Finland	5
Ukraine	81
Lithuania	42
Russian Federation	102
Israel	24
Chile	11
France	2
Czech Republic	122
Hungary	57
Mexico	5
Canada	19
Argentina	122
Belgium	5
Croatia	3
Australia	12
Bulgaria	28
Latvia	26
New Zealand	18
Weight   [units: kilogram (kg)] Mean ± Standard Deviation	73.69  ± 16.17
Height   [units: centimeter (cm)] Mean ± Standard Deviation	164.30  ± 8.88

1.  Primary:

Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years   [ Time Frame: From first dose of CZP to the end of the open-label study (approximately 7 years) ]

2.  Primary:

Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years   [ Time Frame: From first dose of CZP to the end of the open-label study (approximately 7 years) ]

3.  Primary:

Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study   [ Time Frame: From Entry Visit (Week 0) to the end of the study (approximately 6.5 years) ]

4.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48   [ Time Frame: From Baseline of the preceding double-blind study to Week 48 of the open-label study ]

5.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96   [ Time Frame: From Baseline of the preceding double-blind study to Week 96 of the open-label study ]

6.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144   [ Time Frame: From Baseline of the preceding double-blind study to Week 144 of the open-label study ]

7.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192   [ Time Frame: From Baseline of the preceding double-blind study to Week 192 of the open-label study ]

8.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240   [ Time Frame: From Baseline of the preceding double-blind study to Week 240 of the open-label study ]

9.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]

10.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48   [ Time Frame: From Baseline of the preceding double-blind study to Week 48 of the open-label study ]

11.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96   [ Time Frame: From Baseline of the preceding double-blind study to Week 96 of the open-label study ]

12.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144   [ Time Frame: From Baseline of the preceding double-blind study to Week 144 of the open-label study ]

13.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192   [ Time Frame: From Baseline of the preceding double-blind study to Week 192 of the open-label study ]

14.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240   [ Time Frame: From Baseline of the preceding double-blind study to Week 240 of the open-label study ]

15.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]

16.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48   [ Time Frame: From Baseline of the preceding double-blind study to Week 48 of the open-label study ]

17.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96   [ Time Frame: From Baseline of the preceding double-blind study to Week 96 of the open-label study ]

18.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144   [ Time Frame: From Baseline of the preceding double-blind study to Week 144 of the open-label study ]

19.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192   [ Time Frame: From Baseline of the preceding double-blind study to Week 192 of the open-label study ]

20.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240   [ Time Frame: From Baseline of the preceding double-blind study to Week 240 of the open-label study ]

21.  Secondary:

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]

22.  Secondary:

Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)   [ Time Frame: From Baseline of the preceding double-blind study to Week 96 of the open-label study ]

23.  Secondary:

Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire – Disability Index (HAQ-DI) Total Score   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]

24.  Secondary:

Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]

25.  Secondary:

Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]

26.  Secondary:

Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]

27.  Secondary:

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]

28.  Secondary:

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score   [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years) ]