Trial · NCT00299104
A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
NCT00299104, Phase 3, Completed, Genentech, Inc.; results first posted 2011-08-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis. Trials, record NCT00299104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00299104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
- NCT number
- NCT00299104
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 755 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Rheumatoid Arthritis
- Interventions
- folate, methotrexate, methylprednisolone, placebo, rituximab
- First posted
- 2006-03-06
- Last updated
- 2017-07-28
- Results first posted
- 2011-08-10
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 | Baseline and week 52 | Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing. |
| Secondary | Change From Baseline in Modified Sharp Erosion Score at Week 52 | Baseline and week 52 | Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions. |
| Secondary | Percentage of Patients Without Radiographic Progression at Week 52 | Baseline, Week 52 | Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) \<= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change. |
| Secondary | Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52 | Baseline, Week 52 | No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero. |
| Secondary | Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52 | Baseline and week 52 | Rate of progression in structural joint damage (PJD) by change in modified joint space narrowing (JSN) from screening to Week 52. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. |
| Secondary | Change From Baseline in the Modified Total Sharp Score at Week 24 | Baseline, Week 24 | The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing. |
| Secondary | Change From Baseline in the Total Erosion Score at Week 24 | Baseline, Week 24 | Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The Total Erosion Score at Week 24 - Total Erosion Score at baseline is calculated. |
| Secondary | Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24 | Baseline, Week 24 | Joint Space Narrowing is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. |
| Secondary | Percentage of Participants Without Radiographic Progression at Week 24 | Baseline, Week 24 | Percentage of patients without radiographic progression at Week 24 defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change. |
| Secondary | Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52 | Week 52 | To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from: * the physician's global assessment of disease activity * patient's global assessment of disease activity * patient's assessment of pain * HAQ-DI (Health Assessment Questionnaire disability index) * an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.) |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
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 Modified Total Sharp Score (mTSS) From Screening at Week 52 | Baseline and week 52 | Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Modified Sharp Erosion Score at Week 52 | Baseline and week 52 | Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data. | Score on a scale | MEAN |
| SECONDARY | Percentage of Patients Without Radiographic Progression at Week 52 | Baseline, Week 52 | Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing. | Percentage | NUMBER |
| SECONDARY | Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52 | Baseline, Week 52 | Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52 | Baseline and week 52 | Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Modified Total Sharp Score at Week 24 | Baseline, Week 24 | Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time point for analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Total Erosion Score at Week 24 | Baseline, Week 24 | Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) who had data available at Week 24 for analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24 | Baseline, Week 24 | Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) with data available at Week 24 for analysis. | Score on a scale | MEAN |
| SECONDARY | Percentage of Participants Without Radiographic Progression at Week 24 | Baseline, Week 24 | Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52 | Week 52 | Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs). | Percentage of Participants | NUMBER |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group105
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 Modified Total Sharp Score (mTSS) From Screening at Week 52 | Placebo + Methotrexate | 1.079 | Standard Deviation 4.0934 | Score on a scale | |
| Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 | Rituximab (0.5 g x 2) + Methotrexate | 0.646 | Standard Deviation 1.9196 | Score on a scale | |
| Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 | Rituximab (1.0 g x 2) + Methotrexate | 0.359 | Standard Deviation 1.0095 | Score on a scale | |
| Change From Baseline in Modified Sharp Erosion Score at Week 52 | Placebo + Methotrexate | 0.738 | Standard Deviation 2.0480 | Score on a scale | |
| Change From Baseline in Modified Sharp Erosion Score at Week 52 | Rituximab (0.5 g x 2) + Methotrexate | 0.453 | Standard Deviation 1.2065 | Score on a scale | |
| Change From Baseline in Modified Sharp Erosion Score at Week 52 | Rituximab (1.0 g x 2) + Methotrexate | 0.233 | Standard Deviation 0.6252 | Score on a scale | |
| Percentage of Patients Without Radiographic Progression at Week 52 | Placebo + Methotrexate | 53.4 | Percentage | ||
| Percentage of Patients Without Radiographic Progression at Week 52 | Rituximab (0.5 g x 2) + Methotrexate | 57.7 | Percentage | ||
| Percentage of Patients Without Radiographic Progression at Week 52 | Rituximab (1.0 g x 2) + Methotrexate | 63.5 | Percentage | ||
| Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52 | Placebo + Methotrexate | 54.7 | Percentage of Participants |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Placebo + Methotrexate | 251 | |
| Treatment Period | STARTED | Rituximab (0.5 g x 2) + Methotrexate | 252 | |
| Treatment Period | STARTED | Rituximab (1.0 g x 2) + Methotrexate | 252 | |
| Treatment Period | Safety/ITT: Received Study Drug | Placebo + Methotrexate | 249 | |
| Treatment Period | Safety/ITT: Received Study Drug | Rituximab (0.5 g x 2) + Methotrexate | 249 | |
| Treatment Period | Safety/ITT: Received Study Drug | Rituximab (1.0 g x 2) + Methotrexate | 250 | |
| Treatment Period | Completed Week 24 | Placebo + Methotrexate | 227 | |
| Treatment Period | Completed Week 24 | Rituximab (0.5 g x 2) + Methotrexate | 240 | |
| Treatment Period | Completed Week 24 | Rituximab (1.0 g x 2) + Methotrexate | 241 | |
| Treatment Period | Completed Week 52 | Placebo + Methotrexate | 213 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events537
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 | Infusion Related Reaction | Injury, poisoning and procedural complications | Placebo + Methotrexate | 53 | 249 | |
| other | Infusion Related Reaction | Injury, poisoning and procedural complications | Rituximab (0.5 g x 2) + Methotrexate | 69 | 348 | |
| other | Infusion Related Reaction | Injury, poisoning and procedural complications | Rituximab (1.0 g x 2) + Methotrexate | 67 | 263 | |
| other | Nausea | Gastrointestinal disorders | Placebo + Methotrexate | 42 | 249 | |
| other | Nausea | Gastrointestinal disorders | Rituximab (0.5 g x 2) + Methotrexate | 45 | 348 | |
| other | Nausea | Gastrointestinal disorders | Rituximab (1.0 g x 2) + Methotrexate | 46 | 263 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo + Methotrexate | 44 | 249 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Rituximab (0.5 g x 2) + Methotrexate | 59 | 348 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Rituximab (1.0 g x 2) + Methotrexate | 58 | 263 | |
| other | Nasopharyngitis | Infections and infestations | Placebo + Methotrexate | 43 | 249 |
1 to 10 of 537Source ClinicalTrials.gov
See all 537 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Methotrexate | ||
| Total, all-cause mortality | Rituximab (0.5 g x 2) + Methotrexate | ||
| Total, all-cause mortality | Rituximab (1.0 g x 2) + Methotrexate | ||
| Total, other adverse events | Placebo + Methotrexate | 193 | 249 |
| Total, other adverse events | Rituximab (0.5 g x 2) + Methotrexate | 232 | 348 |
| Total, other adverse events | Rituximab (1.0 g x 2) + Methotrexate | 208 | 263 |
| Total, serious adverse events | Placebo + Methotrexate | 48 | 249 |
| Total, serious adverse events | Rituximab (0.5 g x 2) + Methotrexate | 54 | 348 |
| Total, serious adverse events | Rituximab (1.0 g x 2) + Methotrexate | 58 | 263 |
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 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/NCT00299104
GET https://conductscience.org/api/trials/v1/NCT00299104/registered?page=2