Trial · NCT00760669
An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
NCT00760669, Completed, Janssen Korea, Ltd., Korea; results first posted 2013-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants. Trials, record NCT00760669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00760669
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
- NCT number
- NCT00760669
- Status
- Completed
- Enrollment
- 1,061 participants, actual
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Conditions
- Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Arthritis, Psoriatic
- Interventions
- Infliximab; observational study, Methotrexate; observational study
- First posted
- 2008-09-26
- Last updated
- 2013-10-29
- Results first posted
- 2013-08-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 | 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). |
| Primary | Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 | 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. |
| Primary | Change From Baseline in C-Reactive Protein (CRP) at Week 30 | 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. |
| Primary | Change From Baseline in Number of Swollen Joints at Week 30 | 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. |
| Primary | Change From Baseline in Number of Tender Joints at Week 30 | 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. |
| Primary | Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30 | 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). |
| Primary | Overall Efficacy Assessment | 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. |
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
| Primary | Number of Participants With Unexpected Adverse Events | Baseline up to Week 30 | Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. |
| Primary | Number of Participants With Adverse Drug Reactions | 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". |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 | Baseline and Week 30 | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure. | Millimeter | MEAN |
| PRIMARY | Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 | Baseline and Week 30 | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure. | Millimeter per hour | MEAN |
| PRIMARY | Change From Baseline in C-Reactive Protein (CRP) at Week 30 | Baseline and Week 30 | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure. | Milligram per deciliter | MEAN |
| PRIMARY | Change From Baseline in Number of Swollen Joints at Week 30 | Baseline and Week 30 | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure. | Swollen joints | MEAN |
| PRIMARY | Change From Baseline in Number of Tender Joints at Week 30 | Baseline and Week 30 | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure. | Tender joints | MEAN |
| PRIMARY | Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30 | Baseline and Week 30 | Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it. | ||
| PRIMARY | Overall Efficacy Assessment | Baseline up to Week 30 | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. | Participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 30 | Safety population included all participants who received at least 1 dose of study medication. | Participants | NUMBER |
| PRIMARY | Number of Participants With Unexpected Adverse Events | Baseline up to Week 30 | Safety population included all participants who received at least 1 dose of study medication. | Participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Drug Reactions | Baseline up to Week 30 | Safety population included all participants who received at least 1 dose of study medication. | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 | Participants Receiving Infliximab | Baseline | 7.52 | Standard Deviation 6.68 | Millimeter |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 | Participants Receiving Infliximab | Change at Week 30 | -5.23 | Standard Deviation 4.51 | Millimeter |
| Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 | Participants Receiving Infliximab | Baseline | 60.75 | Standard Deviation 29.84 | Millimeter per hour |
| Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 | Participants Receiving Infliximab | Change at Week 30 | -21.80 | Standard Deviation 29.88 | Millimeter per hour |
| Change From Baseline in C-Reactive Protein (CRP) at Week 30 | Participants Receiving Infliximab | Baseline | 7.94 | Standard Deviation 14.04 | Milligram per deciliter |
| Change From Baseline in C-Reactive Protein (CRP) at Week 30 | Participants Receiving Infliximab | Change at Week 30 | -4.81 | Standard Deviation 11.23 | Milligram per deciliter |
| Change From Baseline in Number of Swollen Joints at Week 30 | Participants Receiving Infliximab | Baseline | 9.75 | Standard Deviation 6.53 | Swollen joints |
| Change From Baseline in Number of Swollen Joints at Week 30 | Participants Receiving Infliximab | Change at Week 30 | -5.46 | Standard Deviation 6.02 | Swollen joints |
| Change From Baseline in Number of Tender Joints at Week 30 | Participants Receiving Infliximab | Baseline | 13.31 | Standard Deviation 7.75 | Tender joints |
| Change From Baseline in Number of Tender Joints at Week 30 | Participants Receiving Infliximab | Change at Week 30 | -7.35 | Standard Deviation 7.42 | Tender joints |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Receiving Infliximab | 1,061 | |
| Overall Study | COMPLETED | Participants Receiving Infliximab | 1,031 | |
| Overall Study | NOT COMPLETED | Participants Receiving Infliximab | 30 |
Source ClinicalTrials.gov
Adverse events89
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Participants Receiving Infliximab | 6 | 1,055 | |
| other | Upper respiratory tract infection | Infections and infestations | Participants Receiving Infliximab | 6 | 1,055 | |
| other | Folliculitis | Infections and infestations | Participants Receiving Infliximab | 2 | 1,055 | |
| other | Arthritis bacterial | Infections and infestations | Participants Receiving Infliximab | 1 | 1,055 | |
| other | Bronchitis | Infections and infestations | Participants Receiving Infliximab | 1 | 1,055 | |
| other | Cellulitis | Infections and infestations | Participants Receiving Infliximab | 1 | 1,055 | |
| other | Chronic tonsillitis | Infections and infestations | Participants Receiving Infliximab | 1 | 1,055 | |
| other | Latent tuberculosis | Infections and infestations | Participants Receiving Infliximab | 1 | 1,055 | |
| other | Oral herpes | Infections and infestations | Participants Receiving Infliximab | 1 | 1,055 | |
| other | Pelvic abscess | Infections and infestations | Participants Receiving Infliximab | 1 | 1,055 |
1 to 10 of 89Source ClinicalTrials.gov
See all 89 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Receiving Infliximab | ||
| Total, other adverse events | Participants Receiving Infliximab | 95 | 1,055 |
| Total, serious adverse events | Participants Receiving Infliximab | 12 | 1,055 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00760669
GET https://conductscience.org/api/trials/v1/NCT00760669/events?page=2