A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00785928

Purpose

To assess the efficacy of LY2127399 versus placebo using ACR50 response scale at 24 weeks

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: LY2127399 Drug: Placebo	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To assess LY2127399 efficacy using the ACR 50 response rate at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the LY2127399 dose-ACR50 response and the dose-ACR20 response relationship at 24 weeks relative to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate LY2127399 safety and tolerability compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To evaluate the potential effect of LY2127399 compared to placebo on patient- reported outcomes as measured by the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To further characterize LY2127399 PK in RA patients on MTX therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To evaluate the ACR50 response rate, individual components of the ACR core set, DAS 28 change over the 24 week study period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the potential effect of LY2127399 compared to placebo on patient- reported outcomes as measured by the Medical Outcomes Study 36 Item Short Form Health Survey (SF-36) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	October 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1 mg LY2127399	Biological: LY2127399 subcutaneously q 4 weeks
7: Placebo Comparator Placebo	Drug: Placebo subcutaneously q 4 wks
2: Experimental 3 mg LY2127399	Biological: LY2127399 subcutaneously q 4 weeks
3: Experimental 10 mg LY2127399	Biological: LY2127399 subcutaneously q 4 weeks
4: Experimental 30 mg LY2127399	Biological: LY2127399 subcutaneously q 4 weeks
5: Experimental 60mg LY2127399	Biological: LY2127399 subcutaneously q 4 weeks
6: Experimental 120mg of LY2127399	Biological: LY2127399 subcutaneously q 4 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have given written informed consent
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis
Current, regular use of Methotrexate, at a stable dose
Other criteria to be reviewed by study doctor

Exclusion Criteria:

Use of excluded medications(reviewed by study doctor)
Have not failed biologic TNFa inhibitor therapy
Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
Evidence of tuberculosis
Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
Other criteria to be reviewed by study doctor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785928

Contacts

Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559

1-317-615-4559

Locations

United States, Alabama
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Huntsville, Alabama, United States, 35801
Contact: Eli Lilly
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Calabasas, California, United States, 91302
Contact: Eli Lilly
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Aventura, Florida, United States, 33180
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Vero Beach, Florida, United States, 32960
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Zephyrhills, Florida, United States, 33542
Contact: Eli Lilly
United States, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Syracuse, New York, United States, 13210
Contact: Eli Lilly
United States, Pennsylvania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19152
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Pottstown, Pennsylvania, United States, 19464
Contact: Eli Lilly
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Eli Lilly

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLy (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12409, H9B-MC-BCDH
Study First Received:	November 3, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00785928
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Arthritis

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009