Surveillance of Humira Injection in Korean Patients

NCT01083121 | Completed Results

• 1 other identifier: P10-053
• Study Type: observational
• Target: 1,779
• Locations: 1 country
• Sites: 77

Brief Summary

Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Crohn's Disease; Psoriasis

Keywords

Postmarketing Drug Surveillance

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.

  From Baseline until up to 70 days after the 3 month study period (total of 160 days).

Secondary Outcomes (1)

• Physician's Global Assessment for Effectiveness

  After 3-month treatment

Study Arms (1)

Adalimumab

Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinics, general hospitals

You may qualify if:

• Adult patients (19 years and above) with one of the following indications:
• Moderately to severely active rheumatoid arthritis or
• active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate or
• severe active ankylosing spondylitis who have had an inadequate response to conventional therapy or
• severely active Crohn's disease who have had no response, intolerance or contraindication to corticosteroid therapy or immunosuppressants or
• moderately to severely active psoriasis patients who have had no response, have intolerance or have contraindication to systemic therapies including cyclosporine, methotrexate or photochemotherapy (PUVA).
• Patients who give verbal or written authorization to use their personal and health data.

You may not qualify if:

• \- Patients with known hypersensitivity to adalimumab or any of its excipients.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Eisai Co., Ltd.: collaborator

Study Sites (77)

Site Reference ID/Investigator# 29724

Ansan, 152-703, South Korea

Location

Site Reference ID/Investigator# 53586

Ansan, 152-703, South Korea

Location

Site Reference ID/Investigator# 29729

Bucheon-si, 420-767, South Korea

Location

Site Reference ID/Investigator# 29009

Bucheon-si, 420-818, South Korea

Location

Site Reference ID/Investigator# 29726

Busan, 602-715, South Korea

Location

Site Reference ID/Investigator# 29733

Busan, 602-739, South Korea

Location

Site Reference ID/Investigator# 28582

Busan, 608-838, South Korea

Location

Site Reference ID/Investigator# 5633

Busan, 611-072, South Korea

Location

Site Reference ID/Investigator# 28608

Cheonan, 330-715, South Korea

Location

Site Reference ID/Investigator# 28996

Cheonan, 330-721, South Korea

Location

Site Reference ID/Investigator# 29735

Daegu, 700-712, South Korea

Location

Site Reference ID/Investigator# 59287

Daegu, 705-717, South Korea

Location

Site Reference ID/Investigator# 29278

Daegu, 705-718, South Korea

Location

Site Reference ID/Investigator# 29279

Daegu, 705-718, South Korea

Location

Site Reference ID/Investigator# 29007

Daejeon, 301-808, South Korea

Location

Site Reference ID/Investigator# 29727

Daejeon, 302-799, South Korea

Location

Site Reference ID/Investigator# 29745

Daejeon, 302-799, South Korea

Location

Site Reference ID/Investigator# 48624

Daejeon, 302-799, South Korea

Location

Site Reference ID/Investigator# 29075

Goyang, 411-706, South Korea

Location

Site Reference ID/Investigator# 29042

Guri-si, 471-701, South Korea

Location

Site Reference ID/Investigator# 59285

Guri-si, 471-701, South Korea

Location

Site Reference ID/Investigator# 29731

Gwangju, 501-717, South Korea

Location

Site Reference ID/Investigator# 81693

Gwangju, 501-717, South Korea

Location

Site Reference ID/Investigator# 29732

Gwangju, 501-757, South Korea

Location

Site Reference ID/Investigator# 29737

Gwangju, 501-757, South Korea

Location

Site Reference ID/Investigator# 29742

Gwangju, 501-757, South Korea

Location

Site Reference ID/Investigator# 28611

Gyeongju, 780-350, South Korea

Location

Site Reference ID/Investigator# 29103

Iksan, 570-711, South Korea

Location

Site Reference ID/Investigator# 29010

Incheon, 403-016, South Korea

Location

Site Reference ID/Investigator# 28589

Jeju City, 690-766, South Korea

Location

Site Reference ID/Investigator# 29080

Jeju City, 690-767, South Korea

Location

Site Reference ID/Investigator# 29743

Jeollabuk-do, 651-180, South Korea

Location

Site Reference ID/Investigator# 29082

Jeonju, 560-750, South Korea

Location

Site Reference ID/Investigator# 29740

Jinju, 660-702, South Korea

Location

Site Reference ID/Investigator# 29172

Masan, 630-522, South Korea

Location

Site Reference ID/Investigator# 29436

Metropolitan City Daejon, 302-718, South Korea

Location

Site Reference ID/Investigator# 28970

Pohang, 790-825, South Korea

Location

Site Reference ID/Investigator# 29723

Seongnam, 463-712, South Korea

Location

Site Reference ID/Investigator# 29722

Seongnam, 463-824, South Korea

Location

Site Reference ID/Investigator# 29738

Seoul, 110-744, South Korea

Location

Site Reference ID/Investigator# 53584

Seoul, 110-744, South Korea

Location

Site Reference ID/Investigator# 59283

Seoul, 120-752, South Korea

Location

Site Reference ID/Investigator# 29452

Seoul, 130-702, South Korea

Location

Site Reference ID/Investigator# 29453

Seoul, 130-702, South Korea

Location

Site Reference ID/Investigator# 53583

Seoul, 130-702, South Korea

Location

Site Reference ID/Investigator# 29728

Seoul, 133-792, South Korea

Location

Site Reference ID/Investigator# 29734

Seoul, 133-792, South Korea

Location

Site Reference ID/Investigator# 29721

Seoul, 134-709, South Korea

Location

Site Reference ID/Investigator# 29029

Seoul, 134-727, South Korea

Location

Site Reference ID/Investigator# 29736

Seoul, 135-710, South Korea

Location

Site Reference ID/Investigator# 59282

Seoul, 135-710, South Korea

Location

Site Reference ID/Investigator# 29741

Seoul, 135-720, South Korea

Location

Site Reference ID/Investigator# 29165

Seoul, 135-895, South Korea

Location

Site Reference ID/Investigator# 29166

Seoul, 136-705, South Korea

Location

Site Reference ID/Investigator# 29011

Seoul, 137-701, South Korea

Location

Site Reference ID/Investigator# 48623

Seoul, 137-701, South Korea

Location

Site Reference ID/Investigator# 63322

Seoul, 137-701, South Korea

Location

Site Reference ID/Investigator# 29748

Seoul, 138-736, South Korea

Location

Site Reference ID/Investigator# 53582

Seoul, 138-736, South Korea

Location

Site Reference ID/Investigator# 29076

Seoul, 139-707, South Korea

Location

Site Reference ID/Investigator# 29034

Seoul, 139-872, South Korea

Location

Site Reference ID/Investigator# 29434

Seoul, 143-729, South Korea

Location

Site Reference ID/Investigator# 29435

Seoul, 143-729, South Korea

Location

Site Reference ID/Investigator# 29744

Seoul, 150-030, South Korea

Location

Site Reference ID/Investigator# 29041

Seoul, 150-071, South Korea

Location

Site Reference ID/Investigator# 29012

Seoul, 150-713, South Korea

Location

Site Reference ID/Investigator# 66654

Seoul, 156-707, South Korea

Location

Site Reference ID/Investigator# 59284

Seoul, 156-755, South Korea

Location

Site Reference ID/Investigator# 29035

Seoul, 158-710, South Korea

Location

Site Reference ID/Investigator# 59286

Seoul, 366-144, South Korea

Location

Site Reference ID/Investigator# 53588

Suwon, 442-723, South Korea

Location

Site Reference ID/Investigator# 29746

Suwon, 443-721, South Korea

Location

Site Reference ID/Investigator# 29739

Taegu, South Korea

Location

Site Reference ID/Investigator# 29085

Uljeongbu, 480-824, South Korea

Location

Site Reference ID/Investigator# 28610

Ulsan, 681-711, South Korea

Location

Site Reference ID/Investigator# 29725

Ulsan, 682-714, South Korea

Location

Site Reference ID/Investigator# 29730

Wŏnju, 220-701, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Psoriasis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Deborah Chee, MD

  AbbVie Ltd.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: March 9, 2010
• Study Start: April 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 21, 2013
• Results First Posted: August 20, 2013

Record last verified: 2013-08

Locations

KR (77)