Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis

This study has been terminated.

(Study is terminated due to lack of efficacy)

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT01285310

First received: November 19, 2010

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Purpose

The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who have had an inadequate response to Methotrexate.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Apremilast Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study, To Compare the Efficacy and Safety of Two Doses of Apremilast (CC-10004) in Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Proportion of participants who achieve an American College of Rheumatology criterion for at least 20% improvement (ACR20) from baseline [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Proportion of participants who achieve an American College of Rheumatology criterion for at least 20% improvement (ACR20) from baseline

Secondary Outcome Measures:

Number of participants with Adverse Events [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
Number of participants with Adverse Events
Change from baseline in physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI])
Proportion of subjects who achieve an ACR20 compared with baseline [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an ACR20 compared with baseline
Change from baseline in physical function (HAQ-DI) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in physical function (HAQ-DI)
Change from baseline in the Medical Outcome Study Short Form-36 Version 2 (SF-36) Physical Function domain [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in the Medical Outcome Study Short Form-36 Version 2 (SF-36) Physical Function domain
Change from baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in the Clinical Disease Activity Index (CDAI)
Proportion of subjects who achieve low disease activity or remission based on the CDAI ≤ 10 [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve low disease activity or remission based on the CDAI ≤ 10
Change from baseline in the Disease Activity Score 28 (DAS28) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in the Disease Activity Score 28 (DAS28) ACR 50), compared with baseline
Percentage change from baseline in the individual ACR components [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Percentage change from baseline in the individual ACR components ), compared with baseline
Change from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)
Proportion of subjects who achieve an improvement of ≥ 0.22 units from baseline in the HAQ-DI [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an improvement of ≥ 0.22 units from baseline in the HAQ-DI
Proportion of subjects who achieve an improvement of at least 4 units from baseline in the FACIT-Fatigue [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an improvement of at least 4 units from baseline in the FACIT-Fatigue
Proportion of subjects who achieve the European League Against Rheumatism (EULAR) response criteria [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve the European League Against Rheumatism (EULAR) response criteria
Proportion of subjects who achieve the American College of Rheumatology criteria for a 50% improvement (ACR 50) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve the American College of Rheumatology criteria for a 50% improvement (ACR 50)
Proportion of subjects who achieve the American College of Rheumatology criteria for a 70% improvement (ACR 70) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve the American College of Rheumatology criteria for a 70% improvement (ACR 70)
Proportion of subjects who achieve an ACR50 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an ACR50
Proportion of subjects who achieve an ACR70 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an ACR70
Change from baseline in the physical function domain score of the SF-36 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in the physical function domain score of the SF-36
Change from baseline in the CDAI [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in the CDAI treatment group
Proportion of subjects who achieve low disease activity or remission based on the CDAI ≤ 10 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve low disease activity or remission based on the CDAI ≤ 10
Change from baseline in the DAS-28 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in the DAS-28
Percentage change from baseline in the individual ACR components [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Percentage change from baseline in the individual ACR components
Change from baseline in the FACIT-Fatigue score [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in the FACIT-Fatigue score
Proportion of subjects who achieve an improvement of ≥ 0.22 units from baseline in the HAQ-DI [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an improvement of ≥ 0.22 units from baseline in the HAQ-DI
Proportion of subjects who achieve an improvement of at least 4 units from baseline in the FACIT-Fatigue [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an improvement of at least 4 units from baseline in the FACIT-Fatigue
Proportion of subjects who achieve the EULAR response criteria [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve the EULAR response criteria
Proportion of subjects who achieve an ACR20 compared with baseline [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an ACR20 compared with baseline
Change from baseline in physical function (HAQ-DI) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Change from baseline in physical function (HAQ-DI)
Change from baseline in the SF-36 physical function domain score [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Change from baseline in the SF-36 physical function domain score
Change from baseline in the CDAI [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Change from baseline in the CDAI
Proportion of subjects who achieve low disease activity or remission based on the CDAI ≤ 10 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve low disease activity or remission based on the CDAI ≤ 10
Change from baseline in the DAS28 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Change from baseline in the DAS28
Percentage change from baseline in the individual ACR components [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Percentage change from baseline in the individual ACR components
Change from baseline in the FACIT-Fatigue [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Change from baseline in the FACIT-Fatigue
Proportion of subjects who achieve an improvement of ≥ 0.22 units from baseline in the HAQ-DI [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an improvement of ≥ 0.22 units from baseline in the HAQ-DI
Proportion of subjects who achieve an ACR50 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an ACR50
Proportion of subjects who achieve an ACR70 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Proportion of subjects who achieve an ACR70
Proportion of subjects who achieve an improvement of at least 4 units from baseline in the FACIT-Fatigue [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an improvement of at least 4 units from baseline in the FACIT-Fatigue
Proportion of subjects who achieve the EULAR response criteria [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve the EULAR response criteria
Proportion of subjects who achieve an ACR20 compared with baseline [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an ACR20 compared with baseline
Change from baseline in physical function (HAQ-DI) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Change from baseline in physical function (HAQ-DI)
Change from baseline in the SF-36 physical function domain score [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Change from baseline in the SF-36 physical function domain score
Change from baseline in the CDAI [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Change from baseline in the CDAI
Proportion of subjects who achieve low disease activity or remission based on the CDAI ≤ 10 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Proportion of subjects who achieve low disease activity or remission based on the CDAI ≤ 10
Change from baseline in the DAS28 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Change from baseline in the DAS28
Percentage change from baseline in the individual ACR components [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Percentage change from baseline in the individual ACR components
Change from baseline in the FACIT-Fatigue [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Change from baseline in the FACIT-Fatigue
Proportion of subjects who achieve an improvement of ≥ 0.22 units from baseline in the HAQ-DI [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an improvement of ≥ 0.22 units from baseline in the HAQ-DI
Proportion of subjects who achieve an ACR50 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an ACR50
Proportion of subjects who achieve an ACR70 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an ACR70
Proportion of subjects who achieve an improvement of at least 4 units from baseline in the FACIT-Fatigue [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an improvement of at least 4 units from baseline in the FACIT-Fatigue
Proportion of subjects who achieve the EULAR response criteria [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Proportion of subjects who achieve the EULAR response criteria

Enrollment:	237
Study Start Date:	December 2010
Estimated Study Completion Date:	October 2013
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Apremilast 20 mg Apremilast 20 mg orally, twice a day	Drug: Apremilast 20 mg Apremilast tablets administered BID for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
Experimental: Apremilast 30 mg Apremilast 30 mg orally, twice a day	Drug: Apremilast 30 mg Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
Placebo Comparator: Placebo Placebo orally, twice a day	Drug: Placebo Placebo tablets administered BID for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Subjects who are nonresponders will advance early to 20 mg Apremilast BID at Week 16.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Adult subjects with active rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria:

• Pregnancy, severe acute or chronic conditions, including serious infections or clinically significant laboratory abnormalities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285310

Show 50 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Randall Stevens, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01285310 History of Changes
Other Study ID Numbers:	CC-10004-RA-002, 2010-019926-15
Study First Received:	November 19, 2010
Last Updated:	July 12, 2012
Health Authority:	United States: Food and Drug Administration Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Celgene Corporation:

Rheumatoid, Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013

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