Completed

SPIRIT-P1A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ixekizumab

+ Ixekizumab

+ Placebo

Drug
Who is being recruted

Arthritis+10

+ Bone Diseases

+ Joint Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: January 8, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

NCT01695239
Principal SponsorEli Lilly and Company
Last updated: January 8, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

417 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesPsoriasisSkin DiseasesSpinal DiseasesSpondylitisSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousSpondylarthritisSpondylarthropathiesArthritis, Psoriatic

Criteria

5 inclusion criteria required to participate
Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
Men must agree to use a reliable method of birth control or remain abstinent during the study
Presence of active psoriatic skin lesion or a personal history of plaque psoriasis (Ps)
Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
Show More Criteria
8 exclusion criteria prevent from participating
Breastfeeding or nursing (lactating) women
Current or prior use of biologic agents for treatment of Ps or PsA
Current use of more than one conventional DMARD
Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).

Group II

Experimental
Administered by 80 mg SC injection every 4 weeks (Q4W).

Group III

Placebo
Placebo for ixekizumab and placebo for adalimumab administered by SC injection.

Group IV

Active Comparator
Administered by 40 mg SC injection Q2W.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 116 locations

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.

Birmingham, United StatesOpen 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. in Google Maps

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.

Huntsville, United States

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.

Tuscaloosa, United States

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.

Little Rock, United States
Completed116 Study Centers