An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: Participant with ankylosing spondylitis, rheumatoid arthritis, psoriasis and psoriatic arthritis will be observed at rheumatology departments in university or general hospitals where they are commonly treated.

About this study

Official title: Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients

Conditions

Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Arthritis, Psoriatic

Being tested

Infliximab; observational study, Methotrexate; observational study

Keywords

Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Arthritis, Psoriatic, Infliximab, Remicade

Medical subject headings

Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Infliximab; observational studyDrug

  Also called Remicade Injection

  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.

• Methotrexate; observational studyDrug

  Participants with RA will receive methotrexate based on physician's clinical judgement.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 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).

   Measured: Baseline and Week 30

2. Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at 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.

   Measured: Baseline and Week 30

3. Change From Baseline in C-Reactive Protein (CRP) at 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.

   Measured: Baseline and Week 30

4. Change From Baseline in Number of Swollen Joints at 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.

   Measured: Baseline and Week 30

5. Change From Baseline in Number of Tender Joints at 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.

   Measured: Baseline and Week 30

6. Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at 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).

   Measured: Baseline and Week 30

7. Overall Efficacy Assessment

   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.

   Measured: Baseline up to Week 30

8. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

   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.

   Measured: Baseline up to Week 30

9. Number of Participants With Unexpected Adverse Events

   Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.

   Measured: Baseline up to Week 30

10. Number of Participants With Adverse Drug Reactions

    Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related".

    Measured: Baseline up to Week 30

11. Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction

    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.

    Measured: Baseline up to Week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted26 Sep 2008 (estimated)
2. Study startMay 2007
3. Primary completionApr 2011
4. Study completionApr 2011

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.