271. Ankylosing spondylitis Clinical trials / Disease details
Clinical trials : 563 / Drugs : 372 - (DrugBank : 72) / Drug target genes : 41 - Drug target pathways : 145
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-002061-54-IT (EUCTR) | 13/10/2016 | 15/11/2018 | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) | Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019 | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | ||
| 2 | NCT02762812 (ClinicalTrials.gov) | January 2016 | 4/4/2016 | Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis | International Multi-center Comparative Double-blind Randomized Clinical Trial to Evaluate Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Patients With Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: BCD-055;Biological: Remicade® | Biocad | NULL | Completed | 18 Years | 65 Years | All | 199 | Phase 3 | Russian Federation |
| 3 | EUCTR2015-002284-42-FI (EUCTR) | 18/09/2015 | 28/08/2015 | The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit | INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify | Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab | READE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1650 | Phase 1 | Finland | ||
| 4 | NCT02605642 (ClinicalTrials.gov) | September 10, 2015 | 2/9/2015 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade | PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB) | Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: CT-P13 | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Completed | 18 Years | N/A | All | 351 | Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy | |
| 5 | NCT02359903 (ClinicalTrials.gov) | February 2015 | 30/1/2015 | Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis | International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Infliximab (BCD-055);Drug: Infliximab (Remicade) | Biocad | NULL | Completed | 18 Years | 65 Years | All | 90 | Phase 1 | Belarus;Russian Federation |
| 6 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH | Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning | Diakonhjemmet Hospital AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Norway | ||||
| 7 | NCT01571206 (ClinicalTrials.gov) | March 2012 | 23/3/2012 | An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1 | An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1 | Ankylosing Spondylitis | Biological: Infliximab | Celltrion | NULL | Completed | 18 Years | 75 Years | Both | 174 | Phase 1 | Korea, Republic of |
| 8 | NCT01148901 (ClinicalTrials.gov) | June 2010 | 21/6/2010 | Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451) | Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®) | Ankylosing Spondylitis | Drug: Infliximab | Merck Sharp & Dohme Corp. | Hospital Universitario Reina Sofia;Dr. Jose María Martos Becerra (Central Radiological Assessment) – Hospital de Alta Resolución, Puente Genil (Spain) | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | Spain |
| 9 | EUCTR2009-016587-36-ES (EUCTR) | 15/03/2010 | 27/01/2010 | Artritis de cadera asociada a la EA. Eficacia y Seguridad del tratamiento precoz con Infliximab (Remicade®) | Artritis de cadera asociada a la EA. Eficacia y Seguridad del tratamiento precoz con Infliximab (Remicade®) | Espondilitis anquilosante MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB | Schering Plough, S.A | NULL | Not Recruiting | Female: yes Male: yes | 70 | Spain | |||
| 10 | EUCTR2006-001579-40-DK (EUCTR) | 16/04/2008 | 04/09/2007 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Spondyloarthropathies MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Remicade INN or Proposed INN: infliximab | Schering-Plough France | NULL | Not Recruiting | Female: yes Male: yes | 120 | France;Hungary;Spain;Denmark | |||
| 11 | NCT00936143 (ClinicalTrials.gov) | January 2008 | 7/7/2009 | Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis | An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis | Spondylitis | Drug: infliximab | Gu Jieruo | NULL | Completed | 16 Years | 65 Years | Both | 70 | Phase 4 | China |
| 12 | EUCTR2006-001579-40-HU (EUCTR) | 18/12/2007 | 19/10/2007 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Spondyloarthropathies MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Remicade INN or Proposed INN: infliximab | Schering-Plough France | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;Hungary;Spain;Denmark | ||
| 13 | EUCTR2006-001579-40-ES (EUCTR) | 31/07/2007 | 04/05/2007 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximabESTUDIO DE LA ENTESITIS PERIFÉRICA CON ECOGRAFÍA DOPPLER EN LAS ESPONDILOARTROPATÍAS TRATADAS CON INFLIXIMAB - EUSpA | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximabESTUDIO DE LA ENTESITIS PERIFÉRICA CON ECOGRAFÍA DOPPLER EN LAS ESPONDILOARTROPATÍAS TRATADAS CON INFLIXIMAB - EUSpA | SpondyloarthropathiesEspondiloartropatias MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Remicade INN or Proposed INN: infliximab | Schering-Plough France | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Denmark;France;Spain | |||
| 14 | NCT00724529 (ClinicalTrials.gov) | June 2007 | 25/7/2008 | Post Marketing Surveillance of Remicade | Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ankylosing Spondylitis | Biological: Infliximab | Janssen Korea, Ltd., Korea | NULL | Completed | N/A | N/A | Both | 938 | Korea, Republic of | |
| 15 | NCT00760669 (ClinicalTrials.gov) | May 2007 | 24/9/2008 | An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants | Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients | Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, Psoriatic | Drug: Infliximab; observational study;Drug: Methotrexate | Janssen Korea, Ltd., Korea | NULL | Completed | N/A | N/A | All | 1061 | Korea, Republic of | |
| 16 | EUCTR2006-005157-29-FR (EUCTR) | 27/04/2007 | 13/04/2007 | EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIM | EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIM | Les patients seront traités par infliximab, avec ou sans méthotrexate associé, selon la pratique habituelle en accord avec le libellé de l’A.M.M. Seuls le nombre de prélèvements sanguins et de visites diffèreront des modalités thérapeutiques habituelles. MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis MedDRA version: 9.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders | Trade Name: Méthotrexate Bellon Comprimé INN or Proposed INN: METHOTREXATE Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | CHRU-TOURS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 17 | EUCTR2006-001579-40-FR (EUCTR) | 02/04/2007 | 26/03/2007 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Spondyloarthropathies MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Remicade INN or Proposed INN: infliximab | Schering-Plough France | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Spain;Denmark | ||
| 18 | EUCTR2005-002460-29-BE (EUCTR) | 17/02/2006 | 08/02/2006 | An Open Extension, Investigator Initiated Trial, to Examine Radiographic progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC | An Open Extension, Investigator Initiated Trial, to Examine Radiographic progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC | Ankylosing spondylitis (AS) | Product Name: Remicade Product Code: cA2 INN or Proposed INN: Infliximab Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain) | Rheumazentrum Ruhrgebiet. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 4 | Finland;Belgium;Germany;United Kingdom | ||
| 19 | EUCTR2005-002460-29-FI (EUCTR) | 20/01/2006 | 12/12/2005 | An Open Label Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC | An Open Label Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC | Ankylosing spondylitis (AS) | Product Name: Remicade Product Code: cA2 INN or Proposed INN: Infliximab Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain) | Rheumazentrum Ruhrgebiet. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Finland;United Kingdom;Germany;Belgium | |||
| 20 | EUCTR2005-002460-29-GB (EUCTR) | 22/12/2005 | 03/10/2005 | An Open Label Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC | An Open Label Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC | Ankylosing spondylitis (AS) | Product Name: Remicade Product Code: cA2 INN or Proposed INN: Infliximab Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain) | Rheumazentrum Ruhrgebiet. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Belgium;Germany;United Kingdom | ||
| 21 | EUCTR2005-002460-29-DE (EUCTR) | 12/09/2005 | 05/07/2005 | An Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASIC | An Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASIC | Ankylosing spondylitis (AS) | Product Name: Remicade Product Code: cA2 INN or Proposed INN: Infliximab Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain) | Rheumazentrum Ruhrgebiet. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Finland;United Kingdom;Germany;Belgium | |||
| 22 | NCT00778869 (ClinicalTrials.gov) | August 2005 | 23/10/2008 | Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED) | Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment Compared to Healthy Controls | Spondylitis, Ankylosing | Biological: Remicade | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 4 | NULL |
| 23 | NCT00779935 (ClinicalTrials.gov) | October 1, 2004 | 23/10/2008 | Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED) | Baseline Serum Vascular Endothelial Growth Factor (VEGF) Concentration as Predictive Factor of Response to Infliximab (Remicade) Therapy in Patients With Active Ankylosing Spondylitis Despite Conventional Treatment: a Multicenter Pilot Study | Spondylitis, Ankylosing | Biological: Remicade | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 44 | Phase 4 | NULL |
| 24 | NCT00779012 (ClinicalTrials.gov) | October 1, 2004 | 23/10/2008 | A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED) | Post-Registration Open-Label, Non-Comparative, Multicenter Study of Rate of Efficacy and Tolerance of the Use of Anti-TNF Chimeric Monoclonal Antibodies (Remicade) in Treatment of Patients With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 42 | Phase 4 | NULL |
| 25 | NCT00725543 (ClinicalTrials.gov) | June 2004 | 25/7/2008 | Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED) | Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | N/A | N/A | All | 358 | N/A | NULL |
| 26 | NCT00818168 (ClinicalTrials.gov) | July 2003 | 6/1/2009 | Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED) | Remicade Safety Line (Ankylosing Spondylitis) | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | 18 Years | N/A | All | 320 | N/A | Germany |
| 27 | NCT01850121 (ClinicalTrials.gov) | January 2003 | 6/5/2013 | Remicade in the Treatment of Patients With Active Ankylosing Spondylitis | Remicade in the Treatment of Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Infliximab | Göteborg University | NULL | Completed | 18 Years | 60 Years | Both | 19 | Sweden | |
| 28 | NCT00207701 (ClinicalTrials.gov) | September 2002 | 13/9/2005 | A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis. | A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy | Ankylosing Spondylitis | Drug: infliximab | Centocor, Inc. | Centocor BV, Netherlands | Completed | 18 Years | N/A | Both | 279 | Phase 3 | NULL |