Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (CLIPPER2)
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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) |
- Occurrence of malignancy [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Occurrence of withdrawals from investigational product [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Physician's Global Assessment of Disease Activity on a 21-circle visual analogue scale [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Patient/Parent Global Assessment on a 21-circle VAS [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- C-reative protein [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- ACR Pediatric 30, 50, 70, 90, and 100 [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Individual components of the ACR Pediatric Assessments [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Pain Assessment on a 21-circle VAS [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Duration of morning stiffness in minutes [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Clinically inactive disease defined as follows per Wallace Criteria [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- The Juvenile Arthritis Disease Activity Score (JADAS) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Overall Back Pain and Nocturnal Back Pain on a 100 mm VAS (ERA subjects only) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Bath Ankylosing Spondylitis Metrology Index [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Body Surface Area (PsA subjects only) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Physician Global Assessment of Psoriasis (PsA subjects only) [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
| Enrollment: | 109 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | February 2021 |
| Estimated Primary Completion Date: | January 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01421069
Show 35 Study Locations
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01421069 History of Changes |
| Other Study ID Numbers: | B1801023, 0881A1-3342, 2010-023802-10 |
| Study First Received: | August 18, 2011 |
| Last Updated: | January 14, 2015 |
| Health Authority: | European Union: European Medicines Agency |
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 Joint Diseases Musculoskeletal Diseases TNFR-Fc fusion protein Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents |
Central Nervous System Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015