An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
|ClinicalTrials.gov Identifier: NCT00760669|
Recruitment Status : Completed
First Posted : September 26, 2008
Results First Posted : August 12, 2013
Last Update Posted : October 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Spondylitis, Ankylosing Arthritis, Rheumatoid Psoriasis Arthritis, Psoriatic||Drug: Infliximab; observational study Drug: Methotrexate; observational study||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||1061 participants|
|Official Title:||Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients|
|Study Start Date :||May 2007|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Participants Receiving Infiximab
Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving infliximab injection will be observed.
Drug: Infliximab; observational study
This is an observational study. Participants with RA, AS and PA receiving induction intravenous infusions (a fluid or a medicine delivered into a vein by way of a needle) of infliximab will be observed. Participants with RA will receive infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks. Participants with AS and PA will receive 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
Other Name: Remicade InjectionDrug: Methotrexate; observational study
Participants with RA will receive methotrexate based on physician's clinical judgement.
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 [ Time Frame: Baseline and Week 30 ]The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).
- Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 [ Time Frame: Baseline and Week 30 ]The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.
- Change From Baseline in C-Reactive Protein (CRP) at Week 30 [ Time Frame: Baseline and Week 30 ]The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.
- Change From Baseline in Number of Swollen Joints at Week 30 [ Time Frame: Baseline and Week 30 ]Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.
- Change From Baseline in Number of Tender Joints at Week 30 [ Time Frame: Baseline and Week 30 ]Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.
- Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30 [ Time Frame: Baseline and Week 30 ]The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
- Overall Efficacy Assessment [ Time Frame: Baseline up to Week 30 ]The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator's discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 30 ]An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Number of Participants With Unexpected Adverse Events [ Time Frame: Baseline up to Week 30 ]Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
- Number of Participants With Adverse Drug Reactions [ Time Frame: Baseline up to Week 30 ]Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related".
- Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction [ Time Frame: Baseline up to Week 30 ]An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760669
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|