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Trial record 1 of 1 for:    NCT00843778
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Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (CERTAIN 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00843778
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : October 31, 2013
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: Certolizumab Pegol
Enrollment 131
Recruitment Details Subjects must have either failed to achieve remission in C87076 [NCT00674362] at Week 20 and/or Week 24 (CDAI >2.8), which was confirmed at Week 24, or must have achieved remission at Week 20, which was confirmed at Week 24, flared up between Week 24 and Week 52 and completed the entire C87076 study through Week 52.
Pre-assignment Details Participant Flow refers to the Enrolled Set consisting of all subjects who gave informed consent.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Period Title: Overall Study
Started 131
Completed 96
Not Completed 35
Reason Not Completed
Adverse Event             15
Lack of Efficacy             14
Loss of efficacy             2
Withdrawal by Subject             4
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Baseline Participants 130
Hide Baseline Analysis Population Description
One subject did not receive treatment during C87080, so it is excluded from the Full Analysis Set (FAS) and Safety Set (SS). Full Analysis Set (FAS) consists of all subjects from the Enrolled Set who were dispensed medication. Safety Set is identical to the FAS.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants
<=18 years
0
   0.0%
Between 18 and 65 years
113
  86.9%
>=65 years
17
  13.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants
52.8  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants
Female
105
  80.8%
Male
25
  19.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants
Austria 15
France 3
Germany 28
Italy 7
Poland 77
1.Primary Outcome
Title Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period
Hide Description A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset and time is after the first study drug administration in C87080, up to 70 days after the last injection.
Time Frame From Entry Visit up to approximately 144 weeks
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Hide Analysis Population Description
Safety Set
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: percentage of participants
70.8
2.Primary Outcome
Title Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period
Hide Description A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
Time Frame From Entry Visit up to approximately 144 weeks
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Hide Analysis Population Description
Safety Set
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: percentage of participants
19.2
3.Secondary Outcome
Title Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit
Hide Description DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High.
Time Frame Completion/Withdrawal Visit (up to approximately Week 136)
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Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 114 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: percentage of participants
34.2
4.Secondary Outcome
Title Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. A lower CDAI score indicating improvement in activity and a higher score indicating a decline activity.
Time Frame Completion/Withdrawal Visit (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 122 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 122
Measure Type: Number
Unit of Measure: percentage of participants
27.9
5.Secondary Outcome
Title Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit
Hide Description SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. <= 3.3 (Remission), >3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High.
Time Frame Completion/Withdrawal Visit (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 120 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: percentage of participants
25.8
6.Secondary Outcome
Title Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit
Hide Description ACR20 response is defined for subjects with at least 20 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.
Time Frame Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: percentage of participants
57.3
7.Secondary Outcome
Title Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit
Hide Description ACR50 response is defined for subjects with at least 50 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.
Time Frame Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: percentage of participants
35.5
8.Secondary Outcome
Title Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit
Hide Description ACR70 response is defined for subjects with at least 70 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.
Time Frame Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 124
Measure Type: Number
Unit of Measure: percentage of participants
15.3
9.Secondary Outcome
Title Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit
Hide Description HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.
Time Frame Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 119
Median (Standard Deviation)
Unit of Measure: units on a scale
-0.36  (0.55)
10.Secondary Outcome
Title Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit
Hide Description Change from Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.
Time Frame Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 102 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.90  (23.72)
11.Secondary Outcome
Title Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit
Hide Description Change from Baseline in Fatigue Assessment Scale (0 to 10, 0 is "No Fatigue" and 10 is "Fatigue as bad as you can imagine") is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.
Time Frame Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 117 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 117
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.23  (2.43)
12.Secondary Outcome
Title Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit
Hide Description Change from Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.
Time Frame Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 119
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.18  (23.73)
13.Secondary Outcome
Title Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit
Hide Description Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. Values below the limit of quantification of 0.41 μg/mL will be set to half the limit of quantification for the summaries (0.205 μg/mL).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Safety Set, 89 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 89
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
17.091
(14.981 to 19.499)
14.Secondary Outcome
Title Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study
Hide Description Antibody positive is defined as Anti-CZP antibody levels > 2.4 units/mL at any visit.
Time Frame Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: percentage of participants
10.0
15.Secondary Outcome
Title Percentage of Subjects Willing to Self-inject at Week 0
Hide Description The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set.
Time Frame Week 0 of this study (C87080 [NCT00843778])
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: percentage of participants
69.2
16.Secondary Outcome
Title Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0
Hide Description The three domains of the PRE SIAQ are feelings about injections, self-confidence, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting completed this pre-self-injection questionnaire. The PRE-SIAQ is taken before the subject's first injection.
Time Frame Week 0 of this study (C87080 [NCT00843778])
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections (N = 66) 7.929  (1.979)
Self-confidence (N = 66) 5.922  (2.174)
Satisfaction with self-injection (N = 66) 7.462  (2.033)
17.Secondary Outcome
Title Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0
Hide Description The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame Week 0 of this study (C87080 [NCT00843778])
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 65 or 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections (N = 66) 8.093  (1.853)
Self-image (N = 66) 8.295  (2.243)
Self-confidence (N = 66) 6.881  (1.839)
Injection-site reactions (N = 66) 9.206  (1.158)
Ease of use (N = 65) 7.376  (1.579)
Satisfaction with self-injection (N = 65) 6.994  (0.909)
18.Secondary Outcome
Title Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2
Hide Description The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 80 or 81subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections (N = 81) 8.076  (1.979)
Self-image (N = 80) 8.313  (2.019)
Self-confidence (N = 80) 6.719  (1.905)
Injection-site reactions (N = 81) 8.984  (1.376)
Ease of use (N = 80) 7.250  (1.790)
Satisfaction with self-injection (N =81) 6.847  (1.184)
19.Secondary Outcome
Title Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4
Hide Description The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 82 or 83 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections (N = 83) 8.213  (1.785)
Self-image (N = 83) 8.434  (1.941)
Self-confidence (N = 83) 6.847  (1.707)
Injection-site reactions (N = 82) 9.013  (1.360)
Ease of use (N = 82) 7.512  (1.607)
Satisfaction with self-injection (N = 83) 6.995  (1.100)
20.Secondary Outcome
Title Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6
Hide Description The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 66, 67 or 68 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections (N = 68) 8.407  (1.732)
Self-image (N = 67) 8.545  (1.854)
Self-confidence (N = 68) 6.777  (2.225)
Injection-site reactions (N = 67) 9.025  (1.357)
Ease of use (N = 66) 7.982  (1.308)
Satisfaction with self-injection (N = 68) 7.068  (1.042)
21.Secondary Outcome
Title Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8
Hide Description The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 78, 79 or 80 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections (N = 80) 8.458  (1.635)
Self-image (N = 80) 8.563  (1.769)
Self-confidence (N = 80) 6.854  (1.842)
Injection-site reactions (N = 78) 9.214  (1.144)
Ease of use (N = 79) 7.585  (1.401)
Satisfaction with self-injection (N = 80) 7.112  (0.971)
22.Secondary Outcome
Title Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10
Hide Description The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 72, 73 or 74 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections (N = 74) 8.446  (1.730)
Self-image (N = 72) 8.472  (1.948)
Self-confidence (N = 74) 7.050  (1.852)
Injection-site reactions (N = 73) 8.908  (1.459)
Ease of use (N = 73) 7.792  (1.488)
Satisfaction with self-injection (N = 73) 7.105  (0.876)
23.Secondary Outcome
Title Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
Hide Description The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 74 or 75 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections (N = 75) 8.467  (1.673)
Self-image (N = 74) 8.446  (2.057)
Self-confidence (N = 75) 7.122  (1.803)
Injection-site reactions (N = 75) 9.038  (1.513)
Ease of use (N = 74) 7.973  (1.335)
Satisfaction with self-injection (N = 75) 7.127  (0.975)
24.Secondary Outcome
Title Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0
Hide Description The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 31 subjects are included in the analysis of this outcome measure, based upon the number of subjects receiving hospital nurse injection at this visit, with an available assessment score at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.588  (0.471)
25.Secondary Outcome
Title Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2
Hide Description The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.688  (0.448)
26.Secondary Outcome
Title Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4
Hide Description The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 35 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.804  (0.340)
27.Secondary Outcome
Title Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6
Hide Description The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.705  (0.388)
28.Secondary Outcome
Title Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8
Hide Description The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 34 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.634  (0.423)
29.Secondary Outcome
Title Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10
Hide Description The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.771  (0.335)
30.Secondary Outcome
Title Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12
Hide Description The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks.

Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.611  (0.652)
Time Frame From entry visit up to approximately 144 weeks
Adverse Event Reporting Description Adverse Events refer to the Safety Set consisting of all enrolled subjects who were dispensed medication.
 
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description

Certolizumab Pegol: 200 mg every two weeks

Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).

Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.

All-Cause Mortality
Certolizumab Pegol
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   25/130 (19.23%)    
Cardiac disorders   
Myocardial Ischaemia * 1  2/130 (1.54%)  2
Endocrine disorders   
Goitre * 1  1/130 (0.77%)  1
Gastrointestinal disorders   
Nausea * 1  1/130 (0.77%)  1
General disorders   
Asthenia * 1  1/130 (0.77%)  1
Hepatobiliary disorders   
Hepatitis Toxic * 1  1/130 (0.77%)  1
Immune system disorders   
Anaphylactic Reaction * 1  1/130 (0.77%)  1
Infections and infestations   
Respiratory Tract Infection * 1  1/130 (0.77%)  1
Bronchitis Acute * 1  1/130 (0.77%)  1
Subcutaneous Abscess * 1  1/130 (0.77%)  1
Wound Infection Staphylococcal * 1  1/130 (0.77%)  1
Lymph Node Tuberculosis * 1  1/130 (0.77%)  1
Tuberculosis * 1  2/130 (1.54%)  2
Nasopharyngitis * 1  1/130 (0.77%)  1
Pyelonephritis Acute * 1  1/130 (0.77%)  1
Injury, poisoning and procedural complications   
Silicosis * 1  1/130 (0.77%)  1
Patella Fracture * 1  1/130 (0.77%)  1
Musculoskeletal and connective tissue disorders   
Knee Deformity * 1  1/130 (0.77%)  1
Joint Destruction * 1  1/130 (0.77%)  1
Joint Instability * 1  1/130 (0.77%)  2
Rheumatoid Arthritis * 1  1/130 (0.77%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung Neoplasm Malignant * 1  1/130 (0.77%)  1
Basal Cell Carcinoma * 1  1/130 (0.77%)  1
Nervous system disorders   
Headache * 1  1/130 (0.77%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  1/130 (0.77%)  1
Reproductive system and breast disorders   
Colpocele * 1  1/130 (0.77%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  2/130 (1.54%)  2
Wheezing * 1  1/130 (0.77%)  1
Cough * 1  1/130 (0.77%)  1
Adenoidal Hypertrophy * 1  1/130 (0.77%)  1
Surgical and medical procedures   
Hip Arthroplasty * 1  1/130 (0.77%)  1
Knee Arthroplasty * 1  1/130 (0.77%)  1
Vascular disorders   
Peripheral Ischaemia * 1  1/130 (0.77%)  1
Hypertension * 1  1/130 (0.77%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   35/130 (26.92%)    
Gastrointestinal disorders   
Diarrhoea * 1  8/130 (6.15%) 
Infections and infestations   
Nasopharyngitis * 1  8/130 (6.15%) 
Pharyngitis * 1  8/130 (6.15%) 
Upper respiratory tract infection * 1  12/130 (9.23%) 
Urinary tract infection * 1  8/130 (6.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00843778    
Other Study ID Numbers: C87080
2007-000830-38 ( EudraCT Number )
First Submitted: January 5, 2009
First Posted: February 13, 2009
Results First Submitted: August 19, 2013
Results First Posted: October 31, 2013
Last Update Posted: January 30, 2014