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Dosing Flexibility Study in Patients With Rheumatoid Arthritis (DoseFlex)

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: NCT00580840
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : March 19, 2012
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE December 27, 2007
Results First Submitted Date  ICMJE December 14, 2011
Results First Posted Date  ICMJE March 19, 2012
Last Update Posted Date August 2, 2018
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
ACR20 responders are 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-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Original Primary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
To assess the clinical efficacy of two dose regimens of certolizumab pegol (200 mg administered Q2W and 400 mg administered Q4W) in combination with MTX as compared to MTX alone for maintenance of clinical response over an additional 16 weeks in patients [ Time Frame: duration of the trial ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
  • Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    ACR20 responders are 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-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
  • Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    ACR50 responders are 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-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
  • Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    ACR70 responders are 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-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
  • Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    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
  • Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    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
  • Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    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.
  • DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients [ Time Frame: Week 16 ]
    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
  • SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients [ Time Frame: Week 16 ]
    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
  • CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients [ Time Frame: Week 16 ]
    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 approvement in activity and a higher score indicating a decline activity.
  • Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    Ratio is defined as the CRP value at Week 16 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
  • Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    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 Week 16 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.
  • Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    ACR50 responders are 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-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
  • Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    ACR70 responders are 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-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
  • Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward. < 2.6 Remission, > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High
  • Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. <= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High
  • Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. Range for CDAI is 0-76 with a lower CDAI score reflects approvement in activity and a higher score reflects a decline.
  • DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Week 34 ]
    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
  • SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Week 34 ]
    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
  • CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Week 34 ]
    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 approvement in activity and a higher score indicating a decline activity.
  • Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    Ratio is defined as the CRP value at Week 34 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.
  • Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 Week 34 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 Week 34 minus the Baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    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 Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18. [ Time Frame: Week 18 up to Week 34 ]
    ACR20 loss are subjects with <20% improvement from Baseline for tender joint count, swollen joint count, and at least 3/5 core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein, 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale at 2 consecutive visits. Subjects losing response for 2 consecutive visits are considered as having the event on the day of the visit where response was first lost.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
Response rate; reduction in disease activity; Achievement of remission [ Time Frame: duration of the trial ]
Current Other Pre-specified Outcome Measures
 (submitted: August 26, 2014)
  • Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients [ Time Frame: Baseline, Week 16 ]
    Ratio is defined as the ESR value at Week 16 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
  • Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    Ratio is defined as the ESR value at Week 34 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.
  • Change From Baseline in PhGADA (Physician's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    Change from Baseline in Physician'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 Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    Change from Baseline in Tender Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
  • Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18 [ Time Frame: Baseline, Week 34 ]
    Change from Baseline in Swollen Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosing Flexibility Study in Patients With Rheumatoid Arthritis
Official Title  ICMJE A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
Brief Summary During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.
Detailed Description

Subjects with a stable methotrexate (MTX) dose enter the run-in period in which certolizumab pegol (CZP) will be administered at a dose of 400 mg (2 injections) at Weeks 0, 2, and 4 and at a dose of 200 mg with placebo (1 injection placebo, 1 injection CZP) at Weeks 6, 8, 10, 12, 14 and 16. The dose of MTX should be stable for at least 2 months prior to the Baseline visit and will remain stable throughout the trial, unless there is a need to reduce the dose for reasons of toxicity.

At the Week 18 visit, subjects who were ACR20 (American College of Rheumatology 20% Improvement) responders at Week 16 will be randomized in a double-blinded way to receive either 400 mg CZP given every 4 weeks and placebo given every 4 weeks given as two injections (alternating CZP and placebo every two weeks) plus MTX, 200 mg CZP and placebo administered every 2 weeks (one injection of each) plus MTX, or Placebo administered as two injections every 2 weeks plus MTX. Non-responders will be withdrawn from the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Certolizumab pegol
    400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
    Other Names:
    • CZP
    • Cimzia
  • Drug: Certolizumab pegol
    200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
    Other Names:
    • CZP
    • Cimzia
  • Other: Placebo
    placebo (saline) administered as two injections every 2 weeks
Study Arms  ICMJE
  • Active Comparator: Certolizumab pegol 400 mg and placebo
    400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
    Interventions:
    • Drug: Certolizumab pegol
    • Other: Placebo
  • Experimental: Certolizumab pegol 200 mg and placebo
    200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
    Interventions:
    • Drug: Certolizumab pegol
    • Other: Placebo
  • Placebo Comparator: Placebo
    Placebo administered as two injections every 2 weeks
    Intervention: Other: Placebo
Publications * Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, Staelens F, Koetse W, Bertin P. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):151-60. doi: 10.1002/acr.22496.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
333
Original Estimated Enrollment  ICMJE
 (submitted: December 26, 2007)
447
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with established adult rheumatoid arthritis currently on Methotrexate for at least 3 months

Exclusion Criteria:

  • All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
  • Previous clinical trials participation and previous biological therapy that could interfere with the results of the present clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT00580840
Other Study ID Numbers  ICMJE C87077
2007-005288-86 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
PRS Account UCB Pharma
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP