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Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Adalimumab (Drug); Methotrexate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AbbVie

Official(s) and/or principal investigator(s):
Marc-André Raymond, PhD, Study Director, Affiliation: AbbVie

Overall contact:
Annie Daudrumez, Phone: 514 832-7498, Email: annie.daudrumez@abbvie.com

Summary

The purpose of this study is to determine the safety and efficacy of the use of the combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in suboptimal responders to ADA monotherapy.

Clinical Details

Official title: Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Proportion of subjects achieving a satisfactory response based on investigator assessment

Proportion of subjects achieving a satisfactory response based on subject self-assessment

Secondary outcome:

Proportion of subjects (primary and secondary sub-optimal responders) achieving reduction in PASI

Proportion of primary and secondary sub-optimal responders achieving a clinical response

Change in Dermatology Life Quality Index (DLQI) scores

Proportion of primary sub-optimal responders achieving reduction in PASI

Proportion of secondary sub-optimal responders achieving reduction in PASI

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subjects who have been on Adalimumab monotherapy every other week (EOW) for at least 16 weeks but, who in the opinion of the Investigator, have shown a sub-optimal response to treatment and have a Physician Global Assessment (PGA) of ≥ 3 and a Psoriasis Area and Severity Index (PASI) of ≥ 5; 2. Subjects who after an initial positive response to Adalimumab monotherapy EOW have a sub-optimal response and have a PGA of ≥ 3 and a PASI of ≥ 5; 3. Subjects who are receiving Adalimumab once weekly must be on Adalimumab EOW for 8 weeks prior to study enrolment; 4. Subjects with at least a 6-month history of chronic plaque Psoriasis; 5. Subject is judged to be in good general health as determined by the principal Investigator based on the results of medical history, laboratory profile, physical examination, chest X-ray (CXR), and 12-lead electrocardiogram (ECG) performed at Screening; 6. Subjects must be evaluated for latent Tuberculosis (TB) infection with a purified protein derivative (PPD) test and chest X-ray. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. Exclusion Criteria: 1. Subject has any contraindications to Methotrexate or Adalimumab; 2. Subject has a previous failed response or poor tolerance to Adalimumab; 3. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study; 4. Subject has a history of clinically significant hematologic (e. g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e. g., fibrosis, cirrhosis, hepatitis); 5. Subject has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease; 6. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Locations and Contacts

Annie Daudrumez, Phone: 514 832-7498, Email: annie.daudrumez@abbvie.com

Site Reference ID/Investigator# 126315, Barrie L4M 6L2, Canada; Recruiting
Site Reference ID/Investigator# 126315, Principal Investigator

Site Reference ID/Investigator# 129016, Barrie L4M 7G1, Canada; Recruiting
Site Reference ID/Investigator# 129016, Principal Investigator

Site Reference ID/Investigator# 128352, Bathurst E2A 4Z9, Canada; Recruiting
Site Reference ID/Investigator# 128352, Principal Investigator

Site Reference ID/Investigator# 126518, Calgary T2G 1B1, Canada; Recruiting
Site Reference ID/Investigator# 126518, Principal Investigator

Site Reference ID/Investigator# 126317, Edmonton T5K 1X3, Canada; Recruiting
Site Reference ID/Investigator# 126317, Principal Investigator

Site Reference ID/Investigator# 129015, Edmonton T6J 5E5, Canada; Recruiting
Site Reference ID/Investigator# 129015, Principal Investigator

Site Reference ID/Investigator# 126352, Hamilton L8N 1V6, Canada; Recruiting
Site Reference ID/Investigator# 126352, Principal Investigator

Site Reference ID/Investigator# 126318, Markham L3P 1X2, Canada; Recruiting
Site Reference ID/Investigator# 126318, Principal Investigator

Site Reference ID/Investigator# 126595, Ottawa K2G 6E2, Canada; Recruiting
Site Reference ID/Investigator# 126595, Principal Investigator

Site Reference ID/Investigator# 126773, Peterborough K9J 5K2, Canada; Recruiting
Site Reference ID/Investigator# 126773, Principal Investigator

Site Reference ID/Investigator# 127634, Richmond Hill L4C 9M7, Canada; Recruiting
Site Reference ID/Investigator# 127634, Principal Investigator

Site Reference ID/Investigator# 133833, Saint-Jerome J7Z 3B8, Canada; Recruiting
Site Reference ID/Investigator# 133833, Principal Investigator

Site Reference ID/Investigator# 126802, St. John's A1A 4Y3, Canada; Recruiting
Site Reference ID/Investigator# 126802, Principal Investigator

Site Reference ID/Investigator# 126978, St. John's A1C 2H5, Canada; Recruiting
Site Reference ID/Investigator# 126978, Principal Investigator

Site Reference ID/Investigator# 126979, St. John's A1A 5E8, Canada; Recruiting
Site Reference ID/Investigator# 126979, Principal Investigator

Site Reference ID/Investigator# 128398, Sudbury P3C 1X8, Canada; Recruiting
Site Reference ID/Investigator# 128398, Principal Investigator

Site Reference ID/Investigator# 126520, Surrey V3R 6A7, Canada; Recruiting
Site Reference ID/Investigator# 126520, Principal Investigator

Site Reference ID/Investigator# 127803, Surrey V3V 0C6, Canada; Recruiting
Site Reference ID/Investigator# 127803, Principal Investigator

Site Reference ID/Investigator# 126519, Toronto M5S 3P4, Canada; Recruiting
Site Reference ID/Investigator# 126519, Principal Investigator

Site Reference ID/Investigator# 127944, Vancouver V5Z 4E8, Canada; Recruiting
Site Reference ID/Investigator# 127944, Principal Investigator

Site Reference ID/Investigator# 126351, Waterloo N2J 1C4, Canada; Recruiting
Site Reference ID/Investigator# 126351, Principal Investigator

Site Reference ID/Investigator# 126521, Westmount H3Z 2S6, Canada; Recruiting
Site Reference ID/Investigator# 126521, Principal Investigator

Site Reference ID/Investigator# 126320, Winnipeg R3C 0N2, Canada; Recruiting
Site Reference ID/Investigator# 126320, Principal Investigator

Additional Information

Starting date: July 2014
Last updated: July 13, 2015

Page last updated: August 23, 2015

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