Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis
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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: NCT00160693 |
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Recruitment Status :
Completed
First Posted : September 12, 2005
Results First Posted : July 9, 2012
Last Update Posted : August 1, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Biological: Certolizumab Pegol | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 402 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis |
| Study Start Date : | March 2003 |
| Actual Primary Completion Date : | February 2011 |
| Actual Study Completion Date : | February 2011 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Certolizumab Pegol |
Biological: Certolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Other Name: Cimzia |
- Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years [ Time Frame: From first dose of CZP up to 8 years ]
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo.
- Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years [ Time Frame: From First Visit (Week 0 in this study) up to 8 years ]
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52 [ Time Frame: From Baseline to Week 52 ]
The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study.
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100 [ Time Frame: From Baseline to Week 100 ]
The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study.
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160 [ Time Frame: From Baseline to Week 160 ]
The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study.
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208 [ Time Frame: From Baseline to Week 208 ]
The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study.
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256 [ Time Frame: From Baseline to Week 256 ]
The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study.
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316 [ Time Frame: From Baseline to Week 316 ]
The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Baseline is Baseline of the respective feeder study.
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit [ Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years ]The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
- Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit [ Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years ]The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
- Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit [ Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years ]The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit [ Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years ]The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.
- Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years [ Time Frame: From First Visit (Week 0 in this study) up to 8 years ]
- Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years [ Time Frame: From First Visit (Week 0 in this study) up to 8 years ]This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participation in CZP trial C87014 or C87011
- If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
- Must have provided written informed consent before undergoing any study procedures
Exclusion Criteria:
- History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
- Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
- Any finding indicative of Tuberculosis at end of previous study
- Known HIV infection
- Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (> 2 times upper limit of normal)
- Hemoglobin (Hgb) levels < 9 g/dL or Hematocrit < 30 %
- Total White Blood Cell (WBC) count of < 3.0 x 100/L (< 3000/mm^3)
- Platelet count < 100 x 100 L (100,000/mm^3)
- Serum creatinine > 1.5 times upper limit of normal based on patient age and sex
- Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
- Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
- Any other condition which the Principal Investigator judges would make patient unsuitable for study participation
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): NCT00160693
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| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Publications of Results:
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00160693 |
| Other Study ID Numbers: |
C87015 2005-002617-21 ( EudraCT Number ) |
| First Posted: | September 12, 2005 Key Record Dates |
| Results First Posted: | July 9, 2012 |
| Last Update Posted: | August 1, 2018 |
| Last Verified: | March 2018 |
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Rheumatoid Arthritis America College of Rheumatology Disease modifying anti-rheumatic drug Certolizumab Pegol (CDP870) |
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Certolizumab Pegol Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |