Trial · NCT02889796
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
NCT02889796, Phase 3, Completed, Gilead Sciences; results first posted 2021-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate. Trials, record NCT02889796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02889796
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
- NCT number
- NCT02889796
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,759 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Rheumatoid Arthritis
- Interventions
- Filgotinib, Placebo to match filgotinib, Adalimumab, Placebo to match adalimumab, MTX
- First posted
- 2016-09-07
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2016-000568-41
- Results first posted
- 2021-01-19
Source ClinicalTrials.gov
Registered outcomes80
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | Week 12 | ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity)participant's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain) health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions,8 components: dressing/ grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders. |
| Secondary | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline; Week 12 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability). |
| Secondary | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12 | Week 12 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP = hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Secondary | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Baseline; Week 24 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces). |
| Secondary | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12 | Week 12 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Secondary | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline; Week 12 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline; Week 12 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue). |
| Secondary | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Weeks 2, 4, 12, and 24 | ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Secondary | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Weeks 36, and 52 | ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Secondary | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Weeks 2, 4, 12, and 24 | ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 registered outcomesOutcomes80
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | Week 12 | The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline; Week 12 | Participants in the Full Analysis Set with available data were analyzed. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12 | Week 12 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Baseline; Week 24 | Participants in the Full Analysis Set with available data were analyzed. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12 | Week 12 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline; Week 12 | Participants in the Full Analysis Set with available data were analyzed. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline; Week 12 | Participants in the Full Analysis Set with available data were analyzed. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Weeks 2, 4, 12, and 24 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Weeks 36, and 52 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Weeks 2, 4, 12, and 24 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 outcomesResults by group1,641
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | Filgotinib 200 mg | 76.6 | 95% Confidence Interval 72.7 to 80.5 | percentage of participants | |
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | Filgotinib 100 mg | 69.8 | 95% Confidence Interval 65.6 to 74.0 | percentage of participants | |
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | Adalimumab | 70.5 | 95% Confidence Interval 65.3 to 75.6 | percentage of participants | |
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | Placebo | 49.9 | 95% Confidence Interval 45.3 to 54.5 | percentage of participants | |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Filgotinib 200 mg | Baseline | 1.59 | Standard Deviation 0.611 | score on a scale |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Filgotinib 100 mg | Baseline | 1.55 | Standard Deviation 0.625 | score on a scale |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Adalimumab | Baseline | 1.59 | Standard Deviation 0.600 | score on a scale |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Placebo | Baseline | 1.63 | Standard Deviation 0.613 | score on a scale |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Filgotinib 200 mg | Change from Baseline at Week 12 | -0.69 | Standard Deviation 0.613 | score on a scale |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Filgotinib 100 mg | Change from Baseline at Week 12 | -0.56 | Standard Deviation 0.564 | score on a scale |
1 to 10 of 1,641Source ClinicalTrials.gov
See all 1,641 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Filgotinib 200 mg | 477 | |
| Overall Study | STARTED | Filgotinib 100 mg | 480 | |
| Overall Study | STARTED | Adalimumab | 325 | |
| Overall Study | STARTED | Placebo to Filgotinib 200 mg | 190 | |
| Overall Study | STARTED | Placebo to Filgotinib 100 mg | 191 | |
| Overall Study | STARTED | Placebo Never Received Filgotinib | 96 | |
| Overall Study | COMPLETED | Filgotinib 200 mg | 424 | |
| Overall Study | COMPLETED | Filgotinib 100 mg | 422 | |
| Overall Study | COMPLETED | Adalimumab | 281 | |
| Overall Study | COMPLETED | Placebo to Filgotinib 200 mg | 181 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events792
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 | Nausea | Gastrointestinal disorders | Filgotinib 200 mg | 26 | 475 | |
| other | Nausea | Gastrointestinal disorders | Filgotinib 100 mg | 16 | 480 | |
| other | Nausea | Gastrointestinal disorders | Adalimumab | 6 | 325 | |
| other | Nausea | Gastrointestinal disorders | Placebo to Filgotinib 200 mg | 4 | 190 | |
| other | Nausea | Gastrointestinal disorders | Placebo to Filgotinib 100 mg | 1 | 191 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 475 | |
| other | Nasopharyngitis | Infections and infestations | Filgotinib 200 mg | 43 | 475 | |
| other | Nasopharyngitis | Infections and infestations | Filgotinib 100 mg | 48 | 480 | |
| other | Nasopharyngitis | Infections and infestations | Adalimumab | 24 | 325 | |
| other | Nasopharyngitis | Infections and infestations | Placebo to Filgotinib 200 mg | 7 | 190 |
1 to 10 of 792Source ClinicalTrials.gov
See all 792 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Filgotinib 200 mg | 3 | 475 |
| Total, all-cause mortality | Filgotinib 100 mg | 1 | 480 |
| Total, all-cause mortality | Adalimumab | 1 | 325 |
| Total, all-cause mortality | Placebo to Filgotinib 200 mg | 1 | 190 |
| Total, all-cause mortality | Placebo to Filgotinib 100 mg | 1 | 191 |
| Total, all-cause mortality | Placebo | 2 | 475 |
| Total, other adverse events | Filgotinib 200 mg | 128 | 475 |
| Total, other adverse events | Filgotinib 100 mg | 142 | 480 |
| Total, other adverse events | Adalimumab | 82 | 325 |
| Total, other adverse events | Placebo to Filgotinib 200 mg | 36 | 190 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers10
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/NCT02889796
GET https://conductscience.org/api/trials/v1/NCT02889796/registered?page=2