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Trial record 2 of 4 for:    psoriatic arthritis | tremfya

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT03158285
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: Guselkumab Drug: Placebo Phase 3

Detailed Description:
This is a study of guselkumab in participants with active PsA who are biologically naive and have had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms, structural damage inhibition and the safety profile of guselkumab in the treatment of PsA. The study will consist of a screening phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24 to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations will be performed in the study at defined schedule.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : February 11, 2020
Estimated Study Completion Date : December 18, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Group 1: Guselkumab
Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 100.
Drug: Guselkumab
Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
Other Name: CNTO 1959

Experimental: Group 2: Guselkumab and Placebo
Participants will receive SC guselkumab 100 mg at Weeks 0 and 4 then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.
Drug: Guselkumab
Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
Other Name: CNTO 1959

Drug: Placebo
Participants will receive matching placebo as SC injection.

Experimental: Group 3: Placebo Followed by Guselkumab
Participants will receive SC placebo q4w from Week 0 to Week 20 and will cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through Week 100.
Drug: Guselkumab
Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
Other Name: CNTO 1959

Drug: Placebo
Participants will receive matching placebo as SC injection.




Primary Outcome Measures :
  1. Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Week 24 ]
    ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).


Secondary Outcome Measures :
  1. Change From Baseline in HAQ-DI Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area).

  2. Percentage of Participants who Achieve an ACR 50 Response at Week 24 [ Time Frame: Week 24 ]
    ACR 50 Response is defined as >= 50 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

  3. Percentage of Participants With a Psoriasis Response of IGA at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [ Time Frame: Week 24 ]
    Psoriasis response is defined as an Investigator's Global Assessment (IGA) psoriasis score of 0 [cleared] or 1 [minimal] and >=2-grade reduction from baseline. The IGA of Psoriasis documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  4. Percentage of Participants who Achieve an ACR 20 Response at Week 16 [ Time Frame: Week 16 ]
    ACR 20 Response is defined as >= 20 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

  5. Change From Baseline in Modified van der Heijde-Sharp (vdH-S) Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score based on x-rays of both hands and both feet. The total score ranges from 0 to 528 with higher scores indicating more joint damage.

  6. Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline [ Time Frame: Week 24 ]
    Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence or absence of pain by applying local pressure to Lateral epicondyle humerus, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).

  7. Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants with Dactylitis at Baseline [ Time Frame: Week 24 ]
    The presence and severity of dactylitis will be assessed in both hands and feet using a scoring system from 0 to 3 (0 = no dactylitis, 1 = mild dactylitis, 2 = moderate dactylitis, and 3 = severe dactylitis).

  8. Change From Baseline in Enthesitis Score (based on Leeds Enthesitis Index [LEI]) at Week 24 Among the Participants with Enthesitis at Baseline [ Time Frame: Baseline and Week 24 ]
    Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence or absence of pain by applying local pressure to Lateral epicondyle humerus, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).

  9. Change From Baseline in Dactylitis Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The presence and severity of dactylitis will be assessed in both hands and feet using a scoring system from 0 to 3 (0 = no dactylitis, 1 = mild dactylitis, 2 = moderate dactylitis, and 3 = severe dactylitis).

  10. Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24 [ Time Frame: Baseline and Week 24 ]
    The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health

  11. Change From Baseline in Disease Activity Score 28 (DAS28) C-reactive Protein (CRP) at Week 24 [ Time Frame: Baseline and Week 24 ]
    The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28(CRP) =0.56×SQRT(tender joints [count:1-28])+0.28×SQRT(swollen joints [count:1-28])+0.36×Ln(CRP value in milligram per Liter [mg/L] +1)+0.014×GH (patient's global assessment of disease activity [arthritis])+0.96. Higher score = more severe disease.

  12. Change From Baseline in SF-36 Mental Component Summary (MCS) at Week 24 [ Time Frame: Baseline and Week 24 ]
    The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.

  13. Percentage of Participants who Achieve an ACR 50 Response at Week 16 [ Time Frame: Week 16 ]
    ACR 50 Response is defined as >= 50 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

  14. Percentage of Participants who Achieve an ACR 70 Response at Week 24 [ Time Frame: Week 24 ]
    ACR 70 Response is defined as >= 70 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
  • Have active PsA as defined by: at least 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (>=) 0.6 milligram per deciLitre (mg/dL) at screening from the central laboratory
  • Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray [single anterior-posterior view] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed. Results must be documented)
  • Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
  • Have active PsA despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
  • Has previously received any biologic treatment
  • Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
  • Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
  • Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate [MTX], sulfasalazine [SSZ], Hydroxychloroquine [HCQ], leflunomide [LEF]) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent
  • Has received apremilast within 4 weeks prior to the first administration of study agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158285


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

  Show 156 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03158285     History of Changes
Other Study ID Numbers: CR108219
CNTO1959PSA3002 ( Other Identifier: Janssen Research & Development, LLC )
2016-001224-63 ( EudraCT Number )
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases