Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

NCT01392326 | Completed Phase 3 Results DMC

• 2 other identifiers: CAIN457F23062011-000276-34
• Study Type: interventional
• Target: 606
• Locations: 19 countries
• Sites: 110

Brief Summary

This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis; PsA; ACR; CASPAR

Outcome Measures

Primary Outcomes (1)

• Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo

  A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)

  Week 24

Secondary Outcomes (9)

• Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline

  Week 24

• Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline

  Week 24

• Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg

  Week 24

• Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg

  Week 24

• Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg

  Week 24

Study Arms (3)

Group 1

EXPERIMENTAL

Secukinumab (75mg)

Drug: Secukinumab (75 mg)

Group 2

EXPERIMENTAL

Secukinumab (150 mg)

Drug: Secukinumab (150 mg)

Group 3

PLACEBO COMPARATOR

Drug: Placebo Comparator

Interventions

Secukinumab (75 mg) DRUG

Secukinumab (75 mg)

Group 1

Secukinumab (150 mg) DRUG

Secukinumab (150 mg)

Group 2

Placebo Comparator DRUG

Placebo Comparator

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
• Rheumatoid factor and anti-CCP antibodies negative
• Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis

You may not qualify if:

• Chest X-ray with evidence of ongoing infectious or malignant process
• Subjects who have previously been treated with more than 3 different TNFα inhibitors
• Subjects taking high potency opioid analgesics

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (110)

Novartis Investigative Site

Anniston, Alabama, 36207-5710, United States

Location

Novartis Investigative Site

Mesa, Arizona, 85202, United States

Location

Novartis Investigative Site

Paradise Valley, Arizona, 85253, United States

Location

Novartis Investigative Site

Upland, California, 91786, United States

Location

Novartis Investigative Site

Tamarac, Florida, 33321, United States

Location

Novartis Investigative Site

Newnan, Georgia, 30263, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02111, United States

Location

Novartis Investigative Site

Eagan, Minnesota, 55121, United States

Location

Novartis Investigative Site

Richmond Heights, Missouri, 63117, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68516, United States

Location

Novartis Investigative Site

Freehold, New Jersey, 07728, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28210, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Novartis Investigative Site

Johnston, Rhode Island, 02919, United States

Location

Novartis Investigative Site

Columbia, South Carolina, 29204, United States

Location

Novartis Investigative Site

North Charleston, South Carolina, 29406, United States

Location

Novartis Investigative Site

Jackson, Tennessee, 38305, United States

Location

Novartis Investigative Site

Benbrook, Texas, 76126, United States

Location

Novartis Investigative Site

Dallas, Texas, 75216, United States

Location

Novartis Investigative Site

Dallas, Texas, 75246, United States

Location

Novartis Investigative Site

Houston, Texas, 77034, United States

Location

Novartis Investigative Site

Houston, Texas, 77074, United States

Location

Novartis Investigative Site

Mesquite, Texas, 75150, United States

Location

Novartis Investigative Site

Seattle, Washington, 98122, United States

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1417EYG, Argentina

Location

Novartis Investigative Site

Caba, Buenos Aires, C1181ACH, Argentina

Location

Novartis Investigative Site

Caba, Buenos Aires, C1419AHN, Argentina

Location

Novartis Investigative Site

Córdoba, Córdoba Province, X5000EOC, Argentina

Location

Novartis Investigative Site

Córdoba, Córdoba Province, X5016KEH, Argentina

Location

Novartis Investigative Site

Córdoba, Córdoba Province, X5022CPU, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S2000CFJ, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S200BHD, Argentina

Location

Novartis Investigative Site

Maroochydore, Queensland, 4558, Australia

Location

Novartis Investigative Site

Malvern, Victoria, 3144, Australia

Location

Novartis Investigative Site

Genk, 3600, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 04023-900, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 04266-010, Brazil

Location

Novartis Investigative Site

Sevlievo, Bulgaria, 5400, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1612, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1709, Bulgaria

Location

Novartis Investigative Site

Pleven, 5800, Bulgaria

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1B 5E8, Canada

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

Novartis Investigative Site

Newmarket, Ontario, L3Y 3R7, Canada

Location

Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Novartis Investigative Site

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Novartis Investigative Site

Bruntál, Czech Republic, 792 01, Czechia

Location

Novartis Investigative Site

Uherské Hradiště, Czech Republic, 686 01, Czechia

Location

Novartis Investigative Site

Zlín, Czech Republic, 760 01, Czechia

Location

Novartis Investigative Site

Berlin, Germany, 12203, Germany

Location

Novartis Investigative Site

Aachen, 52064, Germany

Location

Novartis Investigative Site

Cologne, 50924, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Erlangen, 91056, Germany

Location

Novartis Investigative Site

Gommern, 39245, Germany

Location

Novartis Investigative Site

Hamburg, 22143, Germany

Location

Novartis Investigative Site

Hamburg, 22415, Germany

Location

Novartis Investigative Site

Herne, 44649, Germany

Location

Novartis Investigative Site

Hildesheim, 31134, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Nuremberg, 90429, Germany

Location

Novartis Investigative Site

Ratingen, 40882, Germany

Location

Novartis Investigative Site

Zerbst, 39261, Germany

Location

Novartis Investigative Site

Ashkelon, 78278, Israel

Location

Novartis Investigative Site

Haifa, 3339419, Israel

Location

Novartis Investigative Site

Ramat Gan, 5266202, Israel

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Valeggio sul Mincio, (vr), 37067, Italy

Location

Novartis Investigative Site

Catania, CT, 95100, Italy

Location

Novartis Investigative Site

Prato, PO, 59100, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Lipa City, Batangas, 4217, Philippines

Location

Novartis Investigative Site

Dasmariñas, Cavite, 4114, Philippines

Location

Novartis Investigative Site

Manila, National Capital Region, 1003, Philippines

Location

Novartis Investigative Site

Manila, Philippines, 1003, Philippines

Location

Novartis Investigative Site

Las Piñas, 1740, Philippines

Location

Novartis Investigative Site

Manila, 1000, Philippines

Location

Novartis Investigative Site

Manila, 1008, Philippines

Location

Novartis Investigative Site

Quezon City, 1102, Philippines

Location

Novartis Investigative Site

Quezon City, 1121, Philippines

Location

Novartis Investigative Site

Bialystok, 15-351, Poland

Location

Novartis Investigative Site

Warsaw, 02-341, Poland

Location

Novartis Investigative Site

Bucharest, District 1, Romania

Location

Novartis Investigative Site

Iași, Iaşi, 700195, Romania

Location

Novartis Investigative Site

Bucharest, Romania

Location

Novartis Investigative Site

Cluj-Napoca, 400006, Romania

Location

Novartis Investigative Site

Kemerovo, 650029, Russia

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Saint Petersburg, 190068, Russia

Location

Novartis Investigative Site

Yaroslavl, 150003, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620028, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620102, Russia

Location

Novartis Investigative Site

Singapore, Singapore, 119074, Singapore

Location

Novartis Investigative Site

Singapore, Singapore, 169608, Singapore

Location

Novartis Investigative Site

Singapore, Singapore, 529889, Singapore

Location

Novartis Investigative Site

Piešťany, Slovak Republic, 921 12, Slovakia

Location

Novartis Investigative Site

Lučenec, Slovakia, 98401, Slovakia

Location

Novartis Investigative Site

Bangkok, Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

Novartis Investigative Site

Khon Kaen, 40002, Thailand

Location

Novartis Investigative Site

London, England, E11 1NR, United Kingdom

Location

Novartis Investigative Site

Cannock, Staffordshire, WS11 2XY, United Kingdom

Location

Novartis Investigative Site

Bradford, West Yorkshire, BD5 0NA, United Kingdom

Location

Novartis Investigative Site

Glasgow, G12 8TA, United Kingdom

Location

Novartis Investigative Site

London, SE1 9RT, United Kingdom

Location

Related Publications (5)

• Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020 Jan;2(1):18-25. doi: 10.1002/acr2.11097. Epub 2019 Nov 14.

  PMID: 31943974 DERIVED

• Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.

  PMID: 31203228 DERIVED

• Kavanaugh A, Mease PJ, Reimold AM, Tahir H, Rech J, Hall S, Geusens P, Wang Z, Pricop L, Mpofu S; FUTURE-1 Study Group. Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Mar;69(3):347-355. doi: 10.1002/acr.23111.

  PMID: 27696786 DERIVED

• Strand V, Mease P, Gossec L, Elkayam O, van den Bosch F, Zuazo J, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1). Ann Rheum Dis. 2017 Jan;76(1):203-207. doi: 10.1136/annrheumdis-2015-209055. Epub 2016 May 11.

  PMID: 27169431 DERIVED

• Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewe R, Nash P, Pricop L, Yuan J, Richards HB, Mpofu S; FUTURE 1 Study Group. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015 Oct;373(14):1329-39. doi: 10.1056/NEJMoa1412679.

  PMID: 26422723 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 4, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-01

Locations

US (25); CA (5); PL (2); DE (14); AU (2); BR (3); BU (4); BE (3); IT (4); SL (2); GB (5); TH (4); AR (8); RU (6); CZ (3); PH (9); SG (3); RO (4); IL (4)