- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00850343
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Chubu Region, Japan
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Chugoku Region, Japan
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Hokkaido Region, Japan
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Kanto Region, Japan
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Kinki Region, Japan
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Kyushu Region, Japan
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Shikoku Region, Japan
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Tohoku Region, Japan
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Subjects who participated in Study 275-08-003 and meet all of the criteria described below.
- Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.
Exclusion Criteria:
- Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
- Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
- Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
- Patients who required treatment for the same infection at two or more different times during Study 275-08-003
- Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
- Patients whom the investigator has decided to be inappropriate for participation in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Certolizumab pegol 200 mg
Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
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Subkutan (SC) injektion
Andre navne:
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Eksperimentel: Certolizumab pegol 400 mg
Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
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Subkutan (SC) injektion
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With Adverse Events
Tidsramme: From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
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An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. |
From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Tidsramme: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
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Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Tidsramme: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
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Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Tidsramme: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
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Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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Change From Baseline in Disease Activity Score (DAS) 28
Tidsramme: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined. The data before study drug administration of 275-08-003 Study was utilized for Baseline. DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. |
Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
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Change From Baseline in Modified Total Sharp Score (mTSS)
Tidsramme: Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100
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X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers. The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst). |
Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDP870-275-08-004
- JapicCTI-090701
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