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Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

placebo for adalimumab

adalimumab

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of moderate to severe chronic plaque psoriasis
Active psoriasis, despite topical therapies

Exclusion Criteria:

Other active skin diseases or skin infections
Prior exposure to any anti-TNF therapy
Subject has other active skin diseases
Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
Poorly controlled medical conditions
History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
History of cancer or lymphoproliferative disease
History of active TB or listeriosis, or persistent chronic or active infections
Known to have immune deficiency or is immunocompromised
Clinically significant abnormal laboratory test results
Erythrodermic psoriasis or generalized pustular psoriasis

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Psoriasis Area and Severity Index

Adverse Events

Secondary Outcome Measures

Psoriasis Area and Severity Index

DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D

Full Information

NCT ID

NCT00645814

First Posted

March 26, 2008

Last Updated

March 26, 2008

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00645814

Brief Title

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Official Title

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

September 2003 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

placebo for adalimumab

Other Intervention Name(s)

placebo

Intervention Description

80 mg at Week 0 and 40 mg eow through Week 11

Intervention Type

Drug

Intervention Name(s)

adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

80 mg at Week 0 and 40 mg eow through Week 11

Intervention Type

Drug

Intervention Name(s)

adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

80 mg at Week 0 and 40 mg weekly through Week 11

Primary Outcome Measure Information:

Title

Psoriasis Area and Severity Index

Time Frame

Week 12

Title

Adverse Events

Time Frame

Throughout Study Participation

Secondary Outcome Measure Information:

Title

Psoriasis Area and Severity Index

Time Frame

Week 1, 2, 4, 8, 12

Title

DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of moderate to severe chronic plaque psoriasis Active psoriasis, despite topical therapies Exclusion Criteria: Other active skin diseases or skin infections Prior exposure to any anti-TNF therapy Subject has other active skin diseases Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) Poorly controlled medical conditions History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease. History of cancer or lymphoproliferative disease History of active TB or listeriosis, or persistent chronic or active infections Known to have immune deficiency or is immunocompromised Clinically significant abnormal laboratory test results Erythrodermic psoriasis or generalized pustular psoriasis

12. IPD Sharing Statement

Citations:

PubMed Identifier

29380251

Citation

Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

Results Reference

derived

PubMed Identifier

26547918

Citation

Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.

Results Reference

derived

Learn more about this trial

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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