Trial Outcomes & Findings for Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA) (NCT NCT00753454)

NCT ID: NCT00753454

Last Updated: 2018-08-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 168 participants
• Primary outcome timeframe: From Entry Visit up to approximately 60 weeks
• Results posted on: 2018-08-01

Participant Flow

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.

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."

Participant milestones

Measure	CDP870 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 Study STARTED	168
Overall Study COMPLETED	154
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	CDP870 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 Study Adverse Event	4
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	5
Overall Study Investigator Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CDP870 n=168 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	135 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants
Age, Continuous	53.4 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment United States	157 participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants

PRIMARY outcome

Timeframe: From Entry Visit up to approximately 60 weeks

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

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.

Outcome measures

Measure

CDP870 n=168 Participants 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).

Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period

52.4 percentage of subjects

PRIMARY outcome

Timeframe: From Entry Visit up to approximately 60 weeks

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

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.

Outcome measures

Measure

CDP870 n=168 Participants 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).

Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period

2.4 percentage of subjects

PRIMARY outcome

Timeframe: From Entry Visit up to approximately 60 weeks

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

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

Outcome measures

Measure

CDP870 n=168 Participants 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).

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

3.0 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis. Data was not available for 13 subjects.

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.

Outcome measures

Measure

CDP870 n=155 Participants 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).

Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit

73.5 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis. Data was not available for 13 subjects.

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.

Outcome measures

Measure

CDP870 n=155 Participants 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).

Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit

59.4 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis. Data was not available for 13 subjects.

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.

Outcome measures

Measure

CDP870 n=155 Participants 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).

Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit

39.4 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis. Data was not available for 26 subjects.

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.

Outcome measures

Measure

CDP870 n=142 Participants 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).

Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit

-2.94 units on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 145 are included in this analysis. Data was not available for 23 subjects.

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.

Outcome measures

Measure

CDP870 n=145 Participants 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).

Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit

-29.14 units on a scale Standard Deviation 14.62

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 146 are included in this analysis. Data was not available for 22 subjects.

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.

Outcome measures

Measure

CDP870 n=146 Participants 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).

Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit

-28.26 units on a scale Standard Deviation 13.94

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 149 are included in this analysis. Data was not available for 19 subjects.

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.

Outcome measures

Measure

CDP870 n=149 Participants 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).

Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit

32.9 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 151 are included in this analysis. Data was not available for 17 subjects.

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.

Outcome measures

Measure

CDP870 n=151 Participants 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).

Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit

31.1 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 152 are included in this analysis. Data was not available for 16 subjects.

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.

Outcome measures

Measure

CDP870 n=152 Participants 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).

Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit

30.3 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis. Data was not available for 26 subjects.

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.

Outcome measures

Measure

CDP870 n=142 Participants 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).

Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit

-0.67 units on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis. Data was not available for 29 subjects.

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.

Outcome measures

Measure

CDP870 n=139 Participants 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).

Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit

-2.58 units on a scale Standard Deviation 2.51

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis. Data was not available for 25 subjects.

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.

Outcome measures

Measure

CDP870 n=143 Participants 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).

Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit

9.04 units on a scale Standard Deviation 9.69

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis. Data was not available for 25 subjects.

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.

Outcome measures

Measure

CDP870 n=143 Participants 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).

Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit

10.32 units on a scale Standard Deviation 10.5

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis. Data was not available for 25 subjects.

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.

Outcome measures

Measure

CDP870 n=143 Participants 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).

Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit

12.73 units on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis. Data was not available for 27 subjects.

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.

Outcome measures

Measure

CDP870 n=141 Participants 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).

Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit

5.1 units on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis. Data was not available for 27 subjects.

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.

Outcome measures

Measure

CDP870 n=141 Participants 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).

Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit

10.27 units on a scale Standard Deviation 10.27

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis. Data was not available for 25 subjects.

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.

Outcome measures

Measure

CDP870 n=143 Participants 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).

Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit

8.54 units on a scale Standard Deviation 12.29

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis. Data was not available for 27 subjects.

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.

Outcome measures

Measure

CDP870 n=141 Participants 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).

Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit

7 units on a scale Standard Deviation 13.56

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis. Data was not available for 27 subjects.

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.

Outcome measures

Measure

CDP870 n=141 Participants 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).

Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit

5.57 units on a scale Standard Deviation 9.55

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis. Data was not available for 29 subjects.

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.

Outcome measures

Measure

CDP870 n=139 Participants 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).

Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit

10.73 units on a scale Standard Deviation 8.56

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis. Data was not available for 29 subjects.

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.

Outcome measures

Measure

CDP870 n=139 Participants 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).

Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit

5.82 units on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis. Data was not available for 28 subjects.

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.

Outcome measures

Measure

CDP870 n=140 Participants 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).

Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit

-36.04 units on a scale Standard Deviation 27.72

SECONDARY outcome

Timeframe: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)

Population: Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis. Data was not available for 28 subjects.

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.

Outcome measures

Measure

CDP870 n=140 Participants 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).

Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit

-35.51 units on a scale Standard Deviation 27.49

Adverse Events

CDP870

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	CDP870 n=168 participants at risk 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).
Hepatobiliary disorders Cholecystitis	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.
Hepatobiliary disorders Cholelithiasis	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.
Infections and infestations Perirectal Abscess	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.
Infections and infestations Cellulitis	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.
Infections and infestations Urinary Tract Infection	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.
Nervous system disorders Neuropathy Peripheral	0.60% 1/168 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.

Other adverse events

Measure

CDP870 n=168 participants at risk 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).

Infections and infestations Upper Respiratory Tract Infection

13.7% 23/168 • Number of events 23 • Adverse Events (AEs) were collected from Entry Visit up to approximately 60 weeks. Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational product at least once.

Additional Information

UCB (Study Director)

UCB Clinical Trial Call Center

Phone: 1-887-822-9493

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER