Trial · NCT01078389
Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
NCT01078389, Phase 2, Completed, Takeda; results first posted 2014-09-10
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout. Trials, record NCT01078389. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01078389
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
- NCT number
- NCT01078389
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 314 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Joint Damage
- Interventions
- Febuxostat, Placebo for Febuxostat
- First posted
- 2010-03-02
- Last updated
- 2014-09-10
- Results first posted
- 2014-09-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint | Baseline and Month 24 | The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of this single joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst). Individual erosion scores were summed to a maximum erosion score of 5 for joints in the hands and 10 for joints in the feet. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement. |
| Secondary | Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs | Baseline and Month 24 | Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst) for a total JSN score range of 0 to 208. The Erosion Score and the JSN Score were combined for a total possible score of 0 to 528. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement. |
| Secondary | Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs | Baseline and Month 24 | Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement. |
| Secondary | Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint | Baseline and Month 24 | The single affected joint was defined as the joint with the history of the first acute gout flare. Magnetic Resonance Imaging (MRI) was evaluated using the Rheumatoid Arthritis MRI Score (RAMRIS). Bone erosion in the proximal and distal location were each assessed in the affected joint using an 11-point scale where 0=no erosion (best) to 10=91-100% bone eroded (worst) for a bone erosion score range of 0 to 20. Bone marrow edema in the proximal and distal location were each assessed using a 4-point scale where 0=no edema (best) to 3=67-100% edema (worst) for a bone marrow edema (BME) score range of 0 to 6. Synovitis was assessed in the affected joint using a 4-point scale where 0=normal (best) to 3=severe (worst). Higher scores indicated more joint damage. A negative change from Baseline indicated improvement. |
| Secondary | Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint | Baseline and Month 24 | The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of the single affected joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) and Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst). The Erosion Score and the JSN Score were summed for the Total Score. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint | Baseline and Month 24 | Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available for analysis and missing values at Month 24 imputed using linear extrapolation are included in the analysis. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs | Baseline and Month 24 | Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs | Baseline and Month 24 | Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint | Baseline and Month 24 | Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint | Baseline and Month 24 | Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint | Febuxostat 40 mg or 80 mg | Baseline | 0.16 | Standard Deviation 0.444 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint | Placebo | Baseline | 0.11 | Standard Deviation 0.438 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint | Febuxostat 40 mg or 80 mg | Change from Baseline at Month 24 | 0.01 | Standard Deviation 0.330 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint | Placebo | Change from Baseline at Month 24 | 0.01 | Standard Deviation 0.248 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs | Febuxostat 40 mg or 80 mg | Baseline | 4.98 | Standard Deviation 9.707 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs | Placebo | Baseline | 4.56 | Standard Deviation 8.631 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs | Febuxostat 40 mg or 80 mg | Change from Baseline at Month 24 (n=78,74) | 0.31 | Standard Deviation 2.447 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs | Placebo | Change from Baseline at Month 24 (n=78,74) | 0.29 | Standard Deviation 1.746 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs | Febuxostat 40 mg or 80 mg | Baseline | 0.36 | Standard Deviation 1.160 | score on a scale |
| Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs | Placebo | Baseline | 0.17 | Standard Deviation 0.473 | score on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Febuxostat 40 mg or 80 mg | 157 | |
| Overall Study | STARTED | Placebo | 157 | |
| Overall Study | COMPLETED | Febuxostat 40 mg or 80 mg | 93 | |
| Overall Study | COMPLETED | Placebo | 90 | |
| Overall Study | NOT COMPLETED | Febuxostat 40 mg or 80 mg | 64 | |
| Overall Study | NOT COMPLETED | Placebo | 67 |
Source ClinicalTrials.gov
Adverse events108
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 | Diarrhoea | Gastrointestinal disorders | Febuxostat 40 mg or 80 mg | 9 | 157 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 157 | |
| other | Oedema peripheral | General disorders | Febuxostat 40 mg or 80 mg | 8 | 157 | |
| other | Oedema peripheral | General disorders | Placebo | 5 | 157 | |
| other | Upper respiratory tract infection | Infections and infestations | Febuxostat 40 mg or 80 mg | 15 | 157 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 16 | 157 | |
| other | Aspartate aminotransferase increased | Investigations | Febuxostat 40 mg or 80 mg | 11 | 157 | |
| other | Aspartate aminotransferase increased | Investigations | Placebo | 6 | 157 | |
| other | Blood creatine phosphokinase increased | Investigations | Febuxostat 40 mg or 80 mg | 9 | 157 | |
| other | Blood creatine phosphokinase increased | Investigations | Placebo | 11 | 157 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Febuxostat 40 mg or 80 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Febuxostat 40 mg or 80 mg | 73 | 157 |
| Total, other adverse events | Placebo | 67 | 157 |
| Total, serious adverse events | Febuxostat 40 mg or 80 mg | 13 | 157 |
| Total, serious adverse events | Placebo | 11 | 157 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28975718 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Febuxostat 40 mg or 80 mg vs Placebo: serious adverse events |
Source Trial comparisons
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.
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