Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00753454
Previous Study | Return to List | Next Study

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

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

Brief Summary:
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Certolizumab pegol Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to Baseline (W0) or worst swollen and tender joints counts), will be given the option to enroll in C87084 and receive certolizumab pegol [400 mg at Entry, Week 2, and Week 4 followed by 200 mg every two weeks (Q2W)] in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region or until further notice from UCB.

All patients will continue their MTX treatment at the same stable dose as during the C87077 (NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIb, Multi-center Open-label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077.
Study Start Date : September 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 RA in the patient's country or region (or until further notice from UCB).
Drug: Certolizumab pegol
Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 & Week 4, followed by 200 mg every 2 weeks).
Other Name: Cimzia




Primary Outcome Measures :
  1. Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period [ Time Frame: From Entry Visit up to approximately 60 weeks ]

    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.


  2. Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period [ Time Frame: From Entry Visit up to approximately 60 weeks ]

    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.


  3. Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period [ Time Frame: From Entry Visit up to approximately 60 weeks ]

    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


Secondary Outcome Measures :
  1. Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  2. Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  3. Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  4. Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]

    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.


  5. Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]

    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.


  6. Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]

    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.


  7. Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]

    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.


  8. Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]

    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.


  9. Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]

    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.


  10. Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  11. Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  12. Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  13. Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  14. Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  15. Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  16. Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  17. Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  18. Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  19. Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  20. Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  21. Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  22. Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.

  23. Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit [ Time Frame: Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be able to understand the written Informed Consent Form (ICF)
  • Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
  • Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
  • Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
  • Patients must be willing to comply with protocol

Exclusion Criteria:

  • Patients must not have a diagnosis of any other inflammatory Arthritis
  • Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
  • Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
  • Patients who do not meet the Medical History Exclusion criteria, as defined per protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753454


Locations
Layout table for location information
United States, Alabama
Huntsville, Alabama, United States
United States, Arizona
Paradise Valley, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Huntington Beach, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Palm Desert, California, United States
San Diego, California, United States
United States, Florida
Aventura, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Melbourne, Florida, United States
Sarasota, Florida, United States
United States, Illinois
Morton Grove, Illinois, United States
Vernon Hills, Illinois, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Massachusetts
Haverhill, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
Reno, Nevada, United States
United States, New York
Albany, New York, United States
Mineola, New York, United States
Syracuse, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Monroe, North Carolina, United States
Wilmington, North Carolina, United States
United States, Oklahoma
Norman, Oklahoma, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Saint John's, Newfoundland and Labrador, Canada
Canada, Ontario
St. Catharines, Ontario, Canada
Toronto, Ontario, Canada
Sponsors and Collaborators
UCB Pharma
Investigators
Layout table for investigator information
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00753454    
Other Study ID Numbers: C87084
2007-005267-10 ( EudraCT Number )
First Posted: September 16, 2008    Key Record Dates
Results First Posted: June 14, 2012
Last Update Posted: August 1, 2018
Last Verified: July 2012
Keywords provided by UCB Pharma:
Rheumatoid Arthritis
Joint Disease
Arthritis
Certolizumab pegol
Cimzia
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents