Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA) (Dose Flex II)

• ClinicalTrials.gov Identifier: NCT00753454
• Recruitment Status: Completed
• First Posted: September 16, 2008
• Results First Posted: June 14, 2012
• Last Update Posted: August 1, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Intervention: Drug: Certolizumab pegol
• Enrollment: 168

Participant Flow

Recruitment Details	The study started in September 2008 with subjects from Canada and the United States. The primary completion date occurred in May 2011, with study completion in May 2011.
Pre-assignment Details	Participant Flow and Baseline Characteristics refer to the Full Analysis Set (FAS). The Full Analysis Set (FAS) consists of all subjects who were dispensed medication. One subject was discontinued at the discretion of investigator due to "missed visits."

Arm/Group Title	CDP870
Arm/Group Description	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Period Title: Overall Study
Started	168
Completed	154
Not Completed	14
Reason Not Completed
Adverse Event	4
Lack of Efficacy	1
Lost to Follow-up	3
Withdrawal by Subject	5
Investigator Decision	1

Baseline Characteristics

Arm/Group Title		CDP870
Arm/Group Description		Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Baseline Participants		168
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	168 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	135 80.4%
	>=65 years	33 19.6%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	168 participants
		53.4 (12.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	168 participants
	Female	128 76.2%
	Male	40 23.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	168 participants
United States		157
Canada		11

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period
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 date and time is after the first study drug administration in C87084, up to 84 days after the last injection.
Time Frame	From Entry Visit up to approximately 60 weeks

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	168
Measure Type: Number; Unit of Measure: percentage of subjects
	52.4

2. Primary Outcome

Title	Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period
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 date and time is after the first study drug administration in C87084, up to 84 days after the last injection.
Time Frame	From Entry Visit up to approximately 60 weeks

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	168
Measure Type: Number; Unit of Measure: percentage of subjects
	2.4

3. Primary Outcome

Title	Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period
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 60 weeks

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	168
Measure Type: Number; Unit of Measure: percentage of subjects
	3.0

4. Secondary Outcome

Title	Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit
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 C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.

Data was not available for 13 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	155
Measure Type: Number; Unit of Measure: percentage of subjects
	73.5

5. Secondary Outcome

Title	Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit
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 C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.

Data was not available for 13 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	155
Measure Type: Number; Unit of Measure: percentage of subjects
	59.4

6. Secondary Outcome

Title	Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit
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 C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.

Data was not available for 13 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	155
Measure Type: Number; Unit of Measure: percentage of subjects
	39.4

7. Secondary Outcome

Title	Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. < 2.6 Remission, > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.

Data was not available for 26 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	142
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.94 (1.33)

8. Secondary Outcome

Title	Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. <= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 145 are included in this analysis.

Data was not available for 23 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	145
Mean (Standard Deviation); Unit of Measure: units on a scale
	-29.14 (14.62)

9. Secondary Outcome

Title	Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 146 are included in this analysis.

Data was not available for 22 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	146
Mean (Standard Deviation); Unit of Measure: units on a scale
	-28.26 (13.94)

10. 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
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. Missing values were imputed using Non-Responder Imputation (NRI). < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 149 are included in this analysis.

Data was not available for 19 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	149
Measure Type: Number; Unit of Measure: percentage of subjects
	32.9

11. Secondary Outcome

Title	Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit
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. Missing values were imputed using Non-Responder Imputation (NRI). <= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 151 are included in this analysis.

Data was not available for 17 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	151
Measure Type: Number; Unit of Measure: percentage of subjects
	31.1

12. Secondary Outcome

Title	Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit
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. Missing values were imputed using Non-Responder Imputation (NRI). The range for the CDAI is 0 - 76 with a lower CDAI score indicating improvement in activity and a higher score indicating a decline activity.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 152 are included in this analysis.

Data was not available for 16 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	152
Measure Type: Number; Unit of Measure: percentage of subjects
	30.3

13. Secondary Outcome

Title	Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit
Description	HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.

Data was not available for 26 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	142
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.67 (0.59)

14. Secondary Outcome

Title	Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit
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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.

Data was not available for 29 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	139
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.58 (2.51)

15. Secondary Outcome

Title	Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.

Data was not available for 25 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	143
Mean (Standard Deviation); Unit of Measure: units on a scale
	9.04 (9.69)

16. Secondary Outcome

Title	Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.

Data was not available for 25 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	143
Mean (Standard Deviation); Unit of Measure: units on a scale
	10.32 (10.5)

17. Secondary Outcome

Title	Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.

Data was not available for 25 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	143
Mean (Standard Deviation); Unit of Measure: units on a scale
	12.73 (8.9)

18. Secondary Outcome

Title	Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.

Data was not available for 27 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	141
Mean (Standard Deviation); Unit of Measure: units on a scale
	5.1 (7.9)

19. Secondary Outcome

Title	Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.

Data was not available for 27 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	141
Mean (Standard Deviation); Unit of Measure: units on a scale
	10.27 (10.27)

20. Secondary Outcome

Title	Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.

Data was not available for 25 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	143
Mean (Standard Deviation); Unit of Measure: units on a scale
	8.54 (12.29)

21. Secondary Outcome

Title	Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.

Data was not available for 27 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	141
Mean (Standard Deviation); Unit of Measure: units on a scale
	7 (13.56)

22. Secondary Outcome

Title	Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit
Description	There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.

Data was not available for 27 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	141
Mean (Standard Deviation); Unit of Measure: units on a scale
	5.57 (9.55)

23. Secondary Outcome

Title	Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit
Description	PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.

Data was not available for 29 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	139
Mean (Standard Deviation); Unit of Measure: units on a scale
	10.73 (8.56)

24. Secondary Outcome

Title	Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit
Description	MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.

Data was not available for 29 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	139
Mean (Standard Deviation); Unit of Measure: units on a scale
	5.82 (11.3)

25. Secondary Outcome

Title	Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit
Description	Change from Baseline in Patient's Assessment of Arthritis Pain-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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.

Data was not available for 28 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	140
Mean (Standard Deviation); Unit of Measure: units on a scale
	-36.04 (27.72)

26. Secondary Outcome

Title	Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit
Description	Change from Baseline in Patient's Global Assessment of Disease Activity-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. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
Time Frame	Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Outcome Measure Data

Analysis Population Description

Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.

Data was not available for 28 subjects.

Arm/Group Title	CDP870
Arm/Group Description:	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
Overall Number of Participants Analyzed	140
Mean (Standard Deviation); Unit of Measure: units on a scale
	-35.51 (27.49)

Adverse Events

Time Frame	Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks.
Adverse Event Reporting Description	Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.
Arm/Group Title	CDP870
Arm/Group Description	Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
All-Cause Mortality
	CDP870
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	CDP870
	Affected / at Risk (%)	# Events
Total	5/168 (2.98%)
Hepatobiliary disorders
Cholecystitis * 1	1/168 (0.60%)	1
Cholelithiasis * 1	1/168 (0.60%)	1
Infections and infestations
Perirectal Abscess * 1	1/168 (0.60%)	1
Cellulitis * 1	1/168 (0.60%)	1
Urinary Tract Infection * 1	1/168 (0.60%)	1
Musculoskeletal and connective tissue disorders
Pain In Extremity * 1	1/168 (0.60%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma * 1	1/168 (0.60%)	1
Nervous system disorders
Neuropathy Peripheral * 1	1/168 (0.60%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (11.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CDP870
	Affected / at Risk (%)	# Events
Total	23/168 (13.69%)
Infections and infestations
Upper Respiratory Tract Infection * 1	23/168 (13.69%)	23
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (11.1)

Limitations and Caveats

[Not Specified]

More Information

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.

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.

Results Point of Contact

• Name/Title: UCB (Study Director)
• Organization: UCB Clinical Trial Call Center
• Phone: 1-887-822-9493

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00753454
• Other Study ID Numbers: C87084; 2007-005267-10 ( EudraCT Number )
• First Submitted: June 5, 2008
• First Posted: September 16, 2008
• Results First Submitted: May 10, 2012
• Results First Posted: June 14, 2012
• Last Update Posted: August 1, 2018