Skip to main content
OpenTrials
Completed

NCT Number: NCT00674362

Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Graz, Austria

Loading trial locations.

About this study

Treatment period starts with a 24-week, double blind, placebo-controlled, randomized period followed by an open label phase until week 52.

In the double blind phase eligible patients will be randomized via an Interactive Voice Response System (IVRS) in a 1:1 ratio to receive either certolizumab pegol (400 mg at Weeks 0, 2 and 4, followed by 200 mg every two weeks) or placebo up to and including Week 22. All patients will continue to receive their Disease Modifying AntiRheumatic Drugs (DMARDs) therapy established before study entry until Week 52. At Week 24, patients will not receive any injection but will be evaluated:

  • Non-remitters at Week 24 (patients who did not achieve remission at both Week 20 and Week 24) will be discontinued from the study and may be given the opportunity to enter in an open-label follow-up trial, C87080 [NCT00843778], with certolizumab pegol.
  • Remitters (i.e. patients who achieved remission as measured by Clinical Disease Activity Index (CDAI) at both Week 20 and Week 24) will stop their randomized treatment (certolizumab pegol or placebo) and be followed up until Week 52. Remitters who flare up (CDAI ≥11 confirmed at two consecutive visits four weeks apart) between Week 24 and Week 52 will be re-treated with the same dosing regimen of certolizumab pegol (3 administrations of 400mg, given every 2 weeks, followed by 200 mg given every other week) up to and including Week 50.

Remitters who flare up between Week 24 and Week 52 and complete 52-week study period will be allowed to enter open label follow up trial at Week 52.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years

Exclusion criteria

  • All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient
  • Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
  • Patients must not have received any previous biological therapy for rheumatoid arthritis (RA)

Treatment and study plan

Certolizumab Pegol

Biological

Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)

Other names: CDP870, Cimzia

Placebo

Biological

Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)

Primary outcomes

  1. Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24

    Time frame: Week 20 and Week 24

    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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)

Secondary outcomes

  1. 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24

    Time frame: Week 20 and Week 24

    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 (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient 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. Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24

    Time frame: Week 20 and Week 24

    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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-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. Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits

    Time frame: Week 24 up to Week 52

    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 (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI >2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.

  4. Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits

    Time frame: Week 24 up to Week 52

    SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI >3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.

  5. Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits

    Time frame: Week 24 up to Week 52

    DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.

  6. American College of Rheumatology 20% (ACR20) Response at Week 24

    Time frame: Baseline, Week 24

    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)

  7. American College of Rheumatology 50% (ACR50) Response at Week 24

    Time frame: Baseline, Week 24

    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)

  8. American College of Rheumatology 70% (ACR70) Response at Week 24

    Time frame: Baseline, Week 24

    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)

  9. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24

    Time frame: Baseline, Week 24

    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). Change from Baseline is computed as the value at Week 24 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.

  10. Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24

    Time frame: Baseline, Week 24

    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.

  11. Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24

    Time frame: Baseline, Week 24

    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

  12. Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24

    Time frame: Baseline, Week 24

    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

  13. Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24

    Time frame: Baseline, Week 24

    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

  14. Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24

    Time frame: Baseline, Week 24

    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

  15. Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24

    Time frame: Baseline, Week 24

    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

  16. Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24

    Time frame: Baseline, Week 24

    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

  17. Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24

    Time frame: Baseline, Week 24

    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

  18. Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24

    Time frame: Baseline, Week 24

    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

  19. Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24

    Time frame: Baseline, Week 24

    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

  20. Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24

    Time frame: Baseline, Week 24

    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 24 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.

  21. Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24

    Time frame: Baseline, Week 24

    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 24 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.

  22. Change From Baseline in Fatigue Assessment Scale at Week 24

    Time frame: Baseline, Week 24

    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 24 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.

Other outcomes

  1. Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits

    Time frame: From Week 24 up to Week 52

    Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared.

  2. Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24

    Time frame: Week 24

    The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).

  3. Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24

    Time frame: Week 24

    The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).

  4. Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24

    Time frame: Week 24

    The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).

  5. Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24

    Time frame: Week 24

    The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission.

  6. Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24

    Time frame: Week 24

    The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission

  7. Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24

    Time frame: Week 24

    The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis

Acronym: CERTAIN

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 7, 2008
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.