Trial · NCT00302952
Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis
NCT00302952, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2014-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis. Trials, record NCT00302952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00302952
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis
- NCT number
- NCT00302952
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Rheumatoid Arthritis
- Interventions
- Lovastatin, Placebo
- First posted
- 2006-03-15
- Last updated
- 2022-09-07
- Results first posted
- 2014-02-12
- Limitations and caveats
- Enrollment was slow and the full sample size was not obtained.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood draw for CRP, an acute phase reactant used to identify the presence of nonspecific inflammation. Change=Day 84 value minus Baseline value. Normal serum CRP reference range in this study is 0-4 mg/L (log transformed: -4.2 to 1.4). Participants with measurements for designated time points were included in analysis. An increased CRP level indicates the presence of inflammation. Reduced CRP levels could mean a decrease in inflammation. |
| Primary | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
| Primary | Change From Baseline in Total Bilirubin, Creatinine, BUN, Phosphorus, Calcium, and Glucose at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
| Primary | Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
| Primary | Change From Baseline in Potassium, Sodium, Chloride, and Total CO2 at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
| Primary | Change From Baseline in CPK at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
| Primary | Change From Baseline in Counts: White Blood Cells (WBC), Neutrophils, Bands, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, and Reticulocytes at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
| Primary | Change From Baseline in Hematocrit (Hct) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
| Primary | Change From Baseline in Red Cell Distribution Width (RDW) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
| Primary | Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal\_laboratory\_values/blood\_tests\_normal\_values.html |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Intent-to-Treat with available data | mg/L | MEAN |
| PRIMARY | Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Safety | U/L | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Disease Activity Score Using C-reactive Protein (DAS28-CRP) on Day 84 | Baseline (Day 0) to Day 84 (Wk 12) | Intent-to-Treat with Available Data | Scores on a scale | MEAN |
| SECONDARY | Percentage of Participants Meeting ACR20 Response Criteria at Day 84 (ACR: American College of Rheumatology) | Day 84 (Wk 12) | Intent-to-Treat with Available Data | Percentage of participants | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline in Serum IgM Rheumatoid Factor by ELISA (ELISA: Enzyme-linked Immunosorbent Assay) | Baseline (Day 0), Day 84 (Wk 12) | Intent-to-Treat with Available Data | IU/mL | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Serum Anti-cyclic Citrullinated Peptide (Anti-CCP) by ELISA (ELISA: Enzyme-linked Immunosorbent Assay) | Baseline ( Day 0), Day 84 (Wk 12) | Intent-to-Treat with Available Data | IU/mL | MEAN |
| PRIMARY | Change From Baseline in Total Bilirubin, Creatinine, BUN, Phosphorus, Calcium, and Glucose at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Safety | mg/dL | MEAN |
| PRIMARY | Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Safety | g/dL | MEAN |
| PRIMARY | Change From Baseline in Potassium, Sodium, Chloride, and Total CO2 at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Safety | mmol/L | MEAN |
| PRIMARY | Change From Baseline in CPK at Day 84 | Baseline (Day 0), Day 84 (Wk 12) | Safety | U/L | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84 | Lovastatin 80 mg | -0.4 | Standard Error 0.2 | mg/L | |
| Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84 | Placebo | -0.3 | Standard Error 0.1 | mg/L | |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84 | Lovastatin 80 mg | Alkaline Phosphatase | -3.0 | Standard Deviation 20.4 | U/L |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84 | Placebo | Alkaline Phosphatase | 0.4 | Standard Deviation 15.6 | U/L |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84 | Lovastatin 80 mg | ALT | -1.8 | Standard Deviation 10.2 | U/L |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84 | Placebo | ALT | 0.7 | Standard Deviation 10.2 | U/L |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84 | Lovastatin 80 mg | AST | -1.2 | Standard Deviation 19.7 | U/L |
| Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84 | Placebo | AST | 0.8 | Standard Deviation 7.3 | U/L |
| Adjusted Mean Change From Baseline in the Disease Activity Score Using C-reactive Protein (DAS28-CRP) on Day 84 | Lovastatin 80 mg | -0.5 | Standard Error 0.2 | Scores on a scale | |
| Adjusted Mean Change From Baseline in the Disease Activity Score Using C-reactive Protein (DAS28-CRP) on Day 84 | Placebo | -0.5 | Standard Error 0.2 | Scores on a scale |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lovastatin 80 mg | 34 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | Started Intent-to-Treat (ITT) | Lovastatin 80 mg | 34 | |
| Overall Study | Started Intent-to-Treat (ITT) | Placebo | 30 | |
| Overall Study | Completed Intent-to-Treat (ITT) | Lovastatin 80 mg | 34 | |
| Overall Study | Completed Intent-to-Treat (ITT) | Placebo | 29 | |
| Overall Study | COMPLETED | Lovastatin 80 mg | 31 | |
| Overall Study | COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | Lovastatin 80 mg | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events34
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 | Anaemia | Blood and lymphatic system disorders | Lovastatin 80 mg | 9 | 34 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 6 | 30 | 8 |
| other | Leukopenia | Blood and lymphatic system disorders | Lovastatin 80 mg | 2 | 34 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 3 | 30 | 3 |
| other | Lymphopenia | Blood and lymphatic system disorders | Lovastatin 80 mg | 3 | 34 | 3 |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 3 | 30 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Lovastatin 80 mg | 1 | 34 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 30 | 5 |
| other | Nausea | Gastrointestinal disorders | Lovastatin 80 mg | 2 | 34 | 2 |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 30 | 5 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lovastatin 80 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Lovastatin 80 mg | 23 | 34 |
| Total, other adverse events | Placebo | 25 | 30 |
| Total, serious adverse events | Lovastatin 80 mg | 1 | 34 |
| Total, serious adverse events | Placebo | 1 | 30 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Lovastatin 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.
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/NCT00302952
GET https://conductscience.org/api/trials/v1/NCT00302952/results?page=2