Trial · NCT00975130
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
NCT00975130, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2012-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2). Trials, record NCT00975130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00975130
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
- NCT number
- NCT00975130
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,366 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Arthritis, Rheumatoid
- Interventions
- SC golimumab, IV golimumab
- First posted
- 2009-09-11
- Last updated
- 2017-04-13
- Other registries' IDs
- eudract:2009-011137-26
- Results first posted
- 2012-12-07
Source ClinicalTrials.gov
Registered outcomes174
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 | Month 6 | EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease \>1.2 units and a final DAS28-ESR \< 3.2 units, while a moderate response was defined as a decrease \> 1.2 units and final DAS28-ESR \>= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR \<= 5.1 units |
| Primary | Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | Start of Month 11, End of Month 12 | The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR \<2.6. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low \< 10mg/wk, medium \>= 10 to \< 15 mg/week, and high \>=15 mg/week). A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR \> 5.1 = high disease activity, DAS28-ESR \< 3.2 to \< =5.1 = low disease activity, and DAS28-ESR \<2.6 = remission. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. |
| Secondary | Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 registered outcomesOutcomes174
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 | Month 6 | The Efficacy Evaluable population in Part 1 of the study excluded participants without a DAS28-ESR at baseline and at least 1 post-line value DAS28-ESR or those that had very poor data quality due to incomplete documentation. | Participants | NUMBER |
| PRIMARY | Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | Start of Month 11, End of Month 12 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Swollen Joints | MEAN |
| SECONDARY | Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Swollen Joints | MEAN |
| SECONDARY | Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Swollen Joints | MEAN |
| SECONDARY | Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Swollen Joints | MEAN |
| SECONDARY | Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Swollen Joints | MEAN |
| SECONDARY | Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Swollen Joints | MEAN |
| SECONDARY | Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Swollen Joints | MEAN |
| SECONDARY | Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6 | Baseline, Month 2, Month 4, Month 6 | The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. | Swollen Joints | MEAN |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 outcomesResults by group1,796
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 | GLM50-SC | 2692 | Participants | ||
| Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | IV-GLM2/SC-GLM50 | Start of Month 11 | 58 | Participants | |
| Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | SC-GLM50 | Start of Month 11 | 64 | Participants | |
| Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | IV-GLM2/SC-GLM50 | End of Month 12 | 59 | Participants | |
| Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 | SC-GLM50 | End of Month 12 | 67 | Participants | |
| Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | GLM50-SC | Low MTX Dose - Month 2 (n =142) | -4.7 | Standard Deviation 4.46 | Swollen Joints |
| Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | GLM50-SC | Low MTX Dose - Month 4 (n=142) | -6.3 | Standard Deviation 5.37 | Swollen Joints |
| Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | GLM50-SC | Low MTX Dose - Month 6 (n=142) | -7.7 | Standard Deviation 5.59 | Swollen Joints |
| Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | GLM50-SC | Medium MTX Dose - Month 2 (n=526) | -4.6 | Standard Deviation 4.45 | Swollen Joints |
| Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 | GLM50-SC | Medium MTX Dose - Month 4 (n=526) | -6.2 | Standard Deviation 4.98 | Swollen Joints |
1 to 10 of 1,796Source ClinicalTrials.gov
See all 1,796 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Part 1 | STARTED | Golimumab 50 mg Subcutaneous (GLM50-SC) | 3,366 | |
| Study Part 1 | STARTED | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | 0 | |
| Study Part 1 | STARTED | SC-GLM50 | 0 | |
| Study Part 1 | COMPLETED | Golimumab 50 mg Subcutaneous (GLM50-SC) | 3,086 | |
| Study Part 1 | COMPLETED | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | 0 | |
| Study Part 1 | COMPLETED | SC-GLM50 | 0 | |
| Study Part 1 | NOT COMPLETED | Golimumab 50 mg Subcutaneous (GLM50-SC) | 280 | |
| Study Part 1 | NOT COMPLETED | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | 0 | |
| Study Part 1 | NOT COMPLETED | SC-GLM50 | 0 | |
| Study Part 2 | STARTED | Golimumab 50 mg Subcutaneous (GLM50-SC) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events612
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 | Golimumab 50 mg Subcutaneous (GLM50-SC) | 0 | 3,357 | 0 |
| other | Nasopharyngitis | Infections and infestations | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | 13 | 245 | 15 |
| other | Nasopharyngitis | Infections and infestations | SC-GLM50 | 18 | 255 | 19 |
| other | Upper respiratory tract infection | Infections and infestations | Golimumab 50 mg Subcutaneous (GLM50-SC) | 0 | 3,357 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | 15 | 245 | 17 |
| other | Upper respiratory tract infection | Infections and infestations | SC-GLM50 | 6 | 255 | 9 |
| serious | Pneumonia | Infections and infestations | Golimumab 50 mg Subcutaneous (GLM50-SC) | 9 | 3,357 | 10 |
| serious | Pneumonia | Infections and infestations | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | 2 | 245 | 2 |
| serious | Pneumonia | Infections and infestations | SC-GLM50 | 1 | 255 | 1 |
| serious | Arthritis bacterial | Infections and infestations | Golimumab 50 mg Subcutaneous (GLM50-SC) | 5 | 3,357 | 5 |
1 to 10 of 612Source ClinicalTrials.gov
See all 612 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Golimumab 50 mg Subcutaneous (GLM50-SC) | ||
| Total, all-cause mortality | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | ||
| Total, all-cause mortality | SC-GLM50 | ||
| Total, other adverse events | Golimumab 50 mg Subcutaneous (GLM50-SC) | 0 | 3,357 |
| Total, other adverse events | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | 28 | 245 |
| Total, other adverse events | SC-GLM50 | 24 | 255 |
| Total, serious adverse events | Golimumab 50 mg Subcutaneous (GLM50-SC) | 203 | 3,357 |
| Total, serious adverse events | Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg | 17 | 245 |
| Total, serious adverse events | SC-GLM50 | 7 | 255 |
Source ClinicalTrials.gov
Papers4
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/NCT00975130
GET https://conductscience.org/api/trials/v1/NCT00975130/registered?page=2