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Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (CLIPPER2)
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01421069
First received: August 18, 2011
Last updated: May 23, 2017
Last verified: May 2017
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Purpose
This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).
| Condition | Intervention | Phase |
|---|---|---|
| Juvenile Idiopahtic Arthritis | Drug: etanercept | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | An Open-label Extension Study To Assess The Long-term Safety And Clinical Benefit Of Etanercept In Children And Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-related Arthritis, Or Psoriatic Arthritis Who Were Previously Enrolled In Protocol 0881a1-3338-ww(b1801014) |
Resource links provided by NLM:
Drug Information available for:
Etanercept
Genetic and Rare Diseases Information Center resources:
Enthesitis-related Juvenile Idiopathic Arthritis
Spondylarthropathy
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Occurrence of malignancy [ Time Frame: up to 8 years ]
Secondary Outcome Measures:
- Occurrence of withdrawals from investigational product [ Time Frame: up to 8 years ]
- Physician's Global Assessment of Disease Activity on a 21-circle visual analogue scale [ Time Frame: up to 8 years ]
- Patient/Parent Global Assessment on a 21-circle VAS [ Time Frame: up to 8 years ]
- C-reative protein [ Time Frame: up to 8 years ]
- Childhood Health Assessment Questionnaire (CHAQ) for subjects less than 18 years of age; Health Assessment Questionnaire (HAQ) for subjects greater than or equal to 18 years of age. [ Time Frame: up to 8 years ]
- ACR Pediatric 30, 50, 70, 90, and 100 [ Time Frame: up to 8 years ]
- Individual components of the ACR Pediatric Assessments [ Time Frame: up to 8 years ]
- Pain Assessment on a 21-circle VAS [ Time Frame: up to 8 years ]
- Duration of morning stiffness in minutes [ Time Frame: up to 8 years ]
- Clinically inactive disease defined as follows per Wallace Criteria [ Time Frame: up to 8 years ]
- The Juvenile Arthritis Disease Activity Score (JADAS) [ Time Frame: up to 8 years ]
- Overall Back Pain and Nocturnal Back Pain on a 100 mm VAS (ERA subjects only) [ Time Frame: up to 8 years ]
- Bath Ankylosing Spondylitis Metrology Index [ Time Frame: up to 8 years ]
- Body Surface Area (PsA subjects only) [ Time Frame: up to 8 years ]
- Physician Global Assessment of Psoriasis (PsA subjects only) [ Time Frame: up to 8 years ]
| Estimated Enrollment: | 109 |
| Actual Study Start Date: | October 10, 2011 |
| Estimated Study Completion Date: | March 8, 2021 |
| Estimated Primary Completion Date: | March 8, 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: etanercept
Subjects aged <18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW). Subjects aged greater than or equal to 18 years or >62 kg will receive etanercept SC at a dose of 50 mg QW. |
Eligibility| Ages Eligible for Study: | 2 Years to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)
Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
Exclusion criteria for subject planning to continue investigational product:
withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).
History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421069
Show 35 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421069
Show 35 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01421069 History of Changes |
| Other Study ID Numbers: |
B1801023 0881A1-3342 ( Other Identifier: Alias Study Number ) 2010-023802-10 ( EudraCT Number ) |
| Study First Received: | August 18, 2011 |
| Last Updated: | May 23, 2017 |
Keywords provided by Pfizer:
|
Use of etanercept to treat pediatric subjects with extended oligoarticular JIA enthestitis related arthritis (ERA) or psoriatic arthritis (PsA). |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
Etanercept Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on July 19, 2017