Back to resultsA Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT P3)
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ixekizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Spondyloarthritis, Spondylarthropathy
Eligibility Criteria
Inclusion Criteria:
- Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
- Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
- Men must agree to use a reliable method of birth control or remain abstinent during the study
- Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
Exclusion Criteria:
- Current or prior use of biologic agents for treatment of Ps or PsA
- Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDS)
- Current use of more than one cDMARDs
- Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
- Serious disorder or illness other than psoriatic arthritis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
Sites / Locations
- Arizona Arthritis & Rheumatology Research
- Arizona Arthritis & Rheumatology Research, PLLC
- Arizona Arthritis Research, PLC
- University of California, Davis - Health Systems
- East Bay Rheumatology Medical Group
- Arthritis & Osteoporosis Treatment Center, PA
- Florida Medical Clinic PA
- Physicians Clinic of Iowa
- Heartland Research Associates
- Klein and Associates MD, PA
- Klein and Associates MD, PA
- University of Massachusetts Medical Center
- Glacier View Research Institute
- Arthritis, Rheumatic & Back Disease Associates
- Weill Cornell Physicians at Brooklyn Heights
- Robert A. Harrell, III, MD
- Pennsylvania Regional Center for Arthritis & Osteoarthritis
- Pioneer Research Solutions
- Arthritis Care & Diagnostic Center P.A.
- Kadlec Clinic Rheumatology
- Seattle Rheumatology Associates, P.L.L.C.
- Arthritis Northwest Rheumatology
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
Ixekizumab Open Label
Ixekizumab
Placebo
IXE80Q2W Non-randomized
Arm Description
Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period. Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.
Outcomes
Primary Outcome Measures
Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])
Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity & severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose & date of last attended visit in Period 3.
Secondary Outcome Measures
Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA
Relapsed participants are defined as participants no longer meeting Coates criteria for MDA. MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or body surface area (BSA) ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)
TJC is the number of tender and painful joints determined for each participant by examination of 68 joints.TJC possible values range from 0 to 68. A lower TJC indicated less number of joints with tenderness. A higher TJC indicated more joint tenderness. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
Loss of Response = Not Meeting less than or equal to 1 TJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)
SJC is the number of swollen joints determined for each participant by examination of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joints with swelling. A higher SJC indicated more joints with swelling. Swelling was defined as palpable fluctuating synovitis of the joint.
Loss of Response = Not Meeting less than or equal to 1 SJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)
The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Loss of Response = Not Meeting less than or equal to 1 PASI total score. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA
BSA is an investigator evaluated measure, where the percentage of involvement of psoriasis on each participant's BSA is assessed. BSA was measured on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. Loss of Response = Not meeting less than or equal to 3% BSA.
Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score
The pain VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two endpoints whereby the respondent places a mark on the line to indicate his or her response The scale ranges from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 15 Pain VAS. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score
Participants scored their overall assessment of their psoriatic arthritis (PsA) activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left.
Loss of Response = Not Meeting less than or equal to 20 PatGA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Loss of Response = Not Meeting less than or equal to 0.5 HAQ-DI. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points
Tender entheseal points was based on the assessment of the 18 entheseal points. Loss of Response = Not Meeting less than or equal to 1 Tender Entheseal Point. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits)
Time to meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits. Time to first response (in weeks) = [(date of first response - date of first injection of study treatment in the Open-Label Treatment Period)+1]/7.
Open-Label Treatment Period ended at the time when a participant was randomized so the end time was not the same for all participants. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA
MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Time to first response (in weeks) = (date of first response - date of first injection of study treatment in the Relapse Period + 1)/7.
Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment group, baseline measure, geographic region, cDMARD use, treatment week, baseline measure-by-treatment week interaction term, and treatment week-by-treatment interaction term as fixed factors.
Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
Full Information
NCT ID
NCT02584855
First Posted
October 16, 2015
Last Updated
October 25, 2019
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT02584855
Brief Title
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Acronym
SPIRIT P3
Official Title
A Phase 3, Multicenter Study With a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period From Week 36 to Week 104 to Evaluate the Long-Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 14, 2015 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Spondyloarthritis, Spondylarthropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
394 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ixekizumab Open Label
Arm Type
Experimental
Arm Description
Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
Arm Title
Ixekizumab
Arm Type
Experimental
Arm Description
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Arm Title
IXE80Q2W Non-randomized
Arm Type
Experimental
Arm Description
Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period.
Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab
Other Intervention Name(s)
LY2439821
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])
Description
Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity & severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose & date of last attended visit in Period 3.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Secondary Outcome Measure Information:
Title
Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA
Description
Relapsed participants are defined as participants no longer meeting Coates criteria for MDA. MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or body surface area (BSA) ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)
Description
TJC is the number of tender and painful joints determined for each participant by examination of 68 joints.TJC possible values range from 0 to 68. A lower TJC indicated less number of joints with tenderness. A higher TJC indicated more joint tenderness. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
Loss of Response = Not Meeting less than or equal to 1 TJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)
Description
SJC is the number of swollen joints determined for each participant by examination of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joints with swelling. A higher SJC indicated more joints with swelling. Swelling was defined as palpable fluctuating synovitis of the joint.
Loss of Response = Not Meeting less than or equal to 1 SJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)
Description
The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Loss of Response = Not Meeting less than or equal to 1 PASI total score. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA
Description
BSA is an investigator evaluated measure, where the percentage of involvement of psoriasis on each participant's BSA is assessed. BSA was measured on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. Loss of Response = Not meeting less than or equal to 3% BSA.
Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score
Description
The pain VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two endpoints whereby the respondent places a mark on the line to indicate his or her response The scale ranges from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 15 Pain VAS. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score
Description
Participants scored their overall assessment of their psoriatic arthritis (PsA) activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left.
Loss of Response = Not Meeting less than or equal to 20 PatGA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Loss of Response = Not Meeting less than or equal to 0.5 HAQ-DI. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points
Description
Tender entheseal points was based on the assessment of the 18 entheseal points. Loss of Response = Not Meeting less than or equal to 1 Tender Entheseal Point. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.
Time Frame
Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Title
Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits)
Description
Time to meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits. Time to first response (in weeks) = [(date of first response - date of first injection of study treatment in the Open-Label Treatment Period)+1]/7.
Open-Label Treatment Period ended at the time when a participant was randomized so the end time was not the same for all participants. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
Time Frame
Open Label Baseline through Double-Blind Randomization (Week 36 to 64)
Title
Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA
Description
MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Time to first response (in weeks) = (date of first response - date of first injection of study treatment in the Relapse Period + 1)/7.
Time Frame
Relapse in MDA After Double Blind Randomization through Week 104 (or Early Termination)
Title
Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment group, baseline measure, geographic region, cDMARD use, treatment week, baseline measure-by-treatment week interaction term, and treatment week-by-treatment interaction term as fixed factors.
Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64.
Time Frame
Baseline, 40 Weeks from Double Blind Randomization (Week 36 to 64)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
Exclusion Criteria:
Current or prior use of biologic agents for treatment of Ps or PsA
Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDS)
Current use of more than one cDMARDs
Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
Serious disorder or illness other than psoriatic arthritis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Research
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Arizona Arthritis Research, PLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
University of California, Davis - Health Systems
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
East Bay Rheumatology Medical Group
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Arthritis & Osteoporosis Treatment Center, PA
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Florida Medical Clinic PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Physicians Clinic of Iowa
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
54203
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Klein and Associates MD, PA
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Klein and Associates MD, PA
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Glacier View Research Institute
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Arthritis, Rheumatic & Back Disease Associates
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Weill Cornell Physicians at Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Robert A. Harrell, III, MD
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Pennsylvania Regional Center for Arthritis & Osteoarthritis
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Pioneer Research Solutions
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Arthritis Care & Diagnostic Center P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Kadlec Clinic Rheumatology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Seattle Rheumatology Associates, P.L.L.C.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Arthritis Northwest Rheumatology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
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.
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
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.
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
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.
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
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.
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
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.
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
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.
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
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.
City
Ceska Lipa
ZIP/Postal Code
470 01
Country
Czechia
Facility Name
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.
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
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.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
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.
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
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.
City
Praha 4 Nusle
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
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.
City
Praha 5
ZIP/Postal Code
15800
Country
Czechia
Facility Name
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.
City
Praha
ZIP/Postal Code
13000
Country
Czechia
Facility Name
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.
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
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.
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
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.
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
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.
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
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.
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
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.
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
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.
City
Tartu
ZIP/Postal Code
50107
Country
Estonia
Facility Name
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City
Chihuahua
ZIP/Postal Code
03100
Country
Mexico
Facility Name
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City
Cuautitlan Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
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City
Durango
ZIP/Postal Code
34000
Country
Mexico
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City
Guadalajara
ZIP/Postal Code
45040
Country
Mexico
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City
Monterrey
ZIP/Postal Code
64610
Country
Mexico
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City
Morelia
ZIP/Postal Code
58260
Country
Mexico
Facility Name
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City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
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City
Bialystok
ZIP/Postal Code
15879
Country
Poland
Facility Name
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City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
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City
Krakow
ZIP/Postal Code
31-023
Country
Poland
Facility Name
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City
Krakow
ZIP/Postal Code
31-501
Country
Poland
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City
Lublin
ZIP/Postal Code
20-582
Country
Poland
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City
Nowa Sol
ZIP/Postal Code
67100
Country
Poland
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City
Nowy Duninow
ZIP/Postal Code
09505
Country
Poland
Facility Name
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City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
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City
Sochaczew
ZIP/Postal Code
96500
Country
Poland
Facility Name
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City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
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City
Warsaw
ZIP/Postal Code
00-465
Country
Poland
Facility Name
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City
Warszawa
ZIP/Postal Code
00660
Country
Poland
Facility Name
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City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
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City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
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City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
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City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
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City
Ekaterinburg
ZIP/Postal Code
620043
Country
Russian Federation
Facility Name
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City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
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City
Moscow
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
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City
Novosibirsk
ZIP/Postal Code
630061
Country
Russian Federation
Facility Name
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City
St. Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
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City
St. Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
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City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
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City
Bratislava
ZIP/Postal Code
83103
Country
Slovakia
Facility Name
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City
Bratislava
ZIP/Postal Code
84231
Country
Slovakia
Facility Name
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City
Kosice
ZIP/Postal Code
040 15
Country
Slovakia
Facility Name
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City
Povazska Bystrica
ZIP/Postal Code
01701
Country
Slovakia
Facility Name
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City
Senica
ZIP/Postal Code
90501
Country
Slovakia
Facility Name
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City
Stara Lubovna
ZIP/Postal Code
06401
Country
Slovakia
Facility Name
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City
Svidnik
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
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City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
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City
Zvolen
ZIP/Postal Code
96001
Country
Slovakia
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City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Facility Name
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City
Kempton Park
ZIP/Postal Code
1619
Country
South Africa
Facility Name
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City
Port Elizabeth
ZIP/Postal Code
6057
Country
South Africa
Facility Name
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City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
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City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
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City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
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City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
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City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
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City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
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City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
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City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
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City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
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City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
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City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
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City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
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City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
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City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
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City
Vinnytsia
ZIP/Postal Code
21030
Country
Ukraine
Facility Name
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City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
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City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
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City
Goodmayes
ZIP/Postal Code
IG7 4DY
Country
United Kingdom
Facility Name
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City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
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City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
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City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
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City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
35393269
Citation
Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.
Results Reference
derived
PubMed Identifier
33682378
Citation
Coates LC, Pillai SG, Tahir H, Valter I, Chandran V, Kameda H, Okada M, Kerr L, Alves D, Park SY, Adams DH, Gallo G, Hufford MM, Hojnik M, Mease PJ, Kavanaugh A; SPIRIT-P3 Study Group. Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a Randomized, Double-Blind Withdrawal Study. Arthritis Rheumatol. 2021 Sep;73(9):1663-1672. doi: 10.1002/art.41716. Epub 2021 Aug 6.
Results Reference
derived
PubMed Identifier
31964419
Citation
Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.
Results Reference
derived
Learn more about this trial
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
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