Trial · NCT03725202
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
NCT03725202, Phase 3, Completed, AbbVie; results first posted 2025-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis. Trials, record NCT03725202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03725202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
- NCT number
- NCT03725202
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 429 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Giant Cell Arteritis (GCA)
- Interventions
- Upadacitinib, Corticosteroid (CS), Placebo
- First posted
- 2018-10-30
- Last updated
- 2026-02-24
- Other registries' IDs
- eudract:2017-003978-13
- Results first posted
- 2025-03-07
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Sustained Remission at Week 52 | From Week 12 to Week 52 | Sustained remission is defined as having achieved absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined corticosteroid (CS) taper regimen. |
| Secondary | Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52 | Week 12 through Week 52 | Sustained complete remission is defined as having absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52; normalization of erythrocyte sedimentation rate (ESR); normalization of high sensitivity C-reactive protein (hs-CRP) and adherence to the protocol-defined CS taper regimen. |
| Secondary | Cumulative Corticosteroid (CS) Exposure Through Week 52 | Baseline up to Week 52 | The cumulative exposure to corticosteroid(s) through Week 52 of the study was documented. |
| Secondary | Time to First Disease Flare Through Week 52 | Baseline up to Week 52 | Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement \> 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose. |
| Secondary | Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52 | Baseline up to Week 52 | The percentage of participants who experience at least 1 disease flare was calculated. Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement \> 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose. |
| Secondary | Percentage of Participants in Complete Remission at Week 52 | At Week 52 | Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to \< 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to \< 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen. |
| Secondary | Percentage of Participants in Complete Remission at Week 24 | At Week 24 | Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to \< 30 mm/hr-- if ESR ≥30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to \< 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen. |
| Secondary | Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52 | Baseline, Week 52 | The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from the Baseline score indicates improvement. |
| Secondary | Number of Disease Flares Per Participant Through Week 52 | Baseline up to Week 52 | The number of disease flares per participant during Period 1 was documented, and was adjusted by the duration of study participation. |
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52 | Baseline, Week 52 | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue, functional fatigue, emotional fatigue, and social consequences of fatigue. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing items worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Sustained Remission at Week 52 | From Week 12 to Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52 | Week 12 through Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Corticosteroid (CS) Exposure Through Week 52 | Baseline up to Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1. As observed analysis; participants who did not have an evaluation on a scheduled visit were excluded from the analysis for that visit. | mg | MEDIAN |
| SECONDARY | Time to First Disease Flare Through Week 52 | Baseline up to Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52 | Baseline up to Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; as observed analysis | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Complete Remission at Week 52 | At Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Complete Remission at Week 24 | At Week 24 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; non-responder imputation incorporating multiple imputation or non-responder imputation only if there were no missing data due to COVID-19 logistic restrictions was used. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52 | Baseline, Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 with both Baseline and post-Baseline visit values | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Disease Flares Per Participant Through Week 52 | Baseline up to Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1; as observed analysis | Disease Flare per Participant per Year | MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52 | Baseline, Week 52 | Full analysis set in Period 1 (FAS1): all randomized participants who received at least 1 dose of study drug in Period 1 with both Baseline and post-Baseline visit values | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Sustained Remission at Week 52 | Placebo + 52-week CS Taper | 29.0 | 95% Confidence Interval 20.6 to 37.5 | percentage of participants | |
| Percentage of Participants Achieving Sustained Remission at Week 52 | 7.5 mg Upadacitinib + 26-week CS Taper | 41.1 | 95% Confidence Interval 31.8 to 50.4 | percentage of participants | |
| Percentage of Participants Achieving Sustained Remission at Week 52 | 15 mg Upadacitinib + 26-week CS Taper | 46.4 | 95% Confidence Interval 39.6 to 53.2 | percentage of participants | |
| Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52 | Placebo + 52-week CS Taper | 16.1 | 95% Confidence Interval 9.3 to 22.9 | percentage of participants | |
| Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52 | 7.5 mg Upadacitinib + 26-week CS Taper | 26.2 | 95% Confidence Interval 17.8 to 34.5 | percentage of participants | |
| Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52 | 15 mg Upadacitinib + 26-week CS Taper | 37.1 | 95% Confidence Interval 30.5 to 43.7 | percentage of participants | |
| Cumulative Corticosteroid (CS) Exposure Through Week 52 | Placebo + 52-week CS Taper | 2882.0 | 95% Confidence Interval 2762.00 to 3253.00 | mg | |
| Cumulative Corticosteroid (CS) Exposure Through Week 52 | 7.5 mg Upadacitinib + 26-week CS Taper | 1905.0 | 95% Confidence Interval 1615.00 to 2265.00 | mg | |
| Cumulative Corticosteroid (CS) Exposure Through Week 52 | 15 mg Upadacitinib + 26-week CS Taper | 1615.0 | 95% Confidence Interval 1615.00 to 1635.00 | mg | |
| Time to First Disease Flare Through Week 52 | Placebo + 52-week CS Taper | 323.0 | 95% Confidence Interval 249.00 to NA | days |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow64
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Baseline - Week 52) | STARTED | Placebo + 52-week CS Taper | 112 | |
| Period 1 (Baseline - Week 52) | STARTED | 7.5 mg Upadacitinib + 26-week CS Taper | 107 | |
| Period 1 (Baseline - Week 52) | STARTED | 15 mg Upadacitinib + 26-week CS Taper | 210 | |
| Period 1 (Baseline - Week 52) | STARTED | Placebo + 52-week CS Taper -> Placebo | 0 | |
| Period 1 (Baseline - Week 52) | STARTED | 7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib | 0 | |
| Period 1 (Baseline - Week 52) | STARTED | 7.5 mg Upadacitinib + 26-week CS Taper -> Placebo | 0 | |
| Period 1 (Baseline - Week 52) | STARTED | 15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib | 0 | |
| Period 1 (Baseline - Week 52) | STARTED | 15 mg Upadacitinib + 26-week CS Taper -> Placebo | 0 | |
| Period 1 (Baseline - Week 52) | Randomized | Placebo + 52-week CS Taper | 112 | |
| Period 1 (Baseline - Week 52) | Randomized | 7.5 mg Upadacitinib + 26-week CS Taper | 107 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 participant flowAdverse events1,424
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 | CATARACT | Eye disorders | Placebo + 52-week CS Taper | 2 | 112 | 2 |
| other | CATARACT | Eye disorders | 7.5 mg Upadacitinib + 26-week CS Taper | 6 | 107 | 7 |
| other | CATARACT | Eye disorders | 15 mg Upadacitinib + 26-week CS Taper | 10 | 210 | 10 |
| other | CATARACT | Eye disorders | Placebo + 52-week CS Taper -> Placebo | 3 | 43 | 4 |
| other | CATARACT | Eye disorders | 7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib | 0 | 39 | 0 |
| other | CATARACT | Eye disorders | 7.5 mg Upadacitinib + 26-week CS Taper -> Placebo | 1 | 14 | 1 |
| other | CATARACT | Eye disorders | 15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib | 2 | 92 | 2 |
| other | CATARACT | Eye disorders | 15 mg Upadacitinib + 26-week CS Taper -> Placebo | 0 | 35 | 0 |
| other | OCULAR HYPERAEMIA | Eye disorders | Placebo + 52-week CS Taper | 0 | 112 | 0 |
| other | OCULAR HYPERAEMIA | Eye disorders | 7.5 mg Upadacitinib + 26-week CS Taper | 0 | 107 | 0 |
1 to 10 of 1,424Source ClinicalTrials.gov
See all 1,424 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + 52-week CS Taper | 2 | 112 |
| Total, all-cause mortality | 7.5 mg Upadacitinib + 26-week CS Taper | 0 | 107 |
| Total, all-cause mortality | 15 mg Upadacitinib + 26-week CS Taper | 3 | 210 |
| Total, all-cause mortality | Placebo + 52-week CS Taper -> Placebo | 0 | 43 |
| Total, all-cause mortality | 7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib | 0 | 39 |
| Total, all-cause mortality | 7.5 mg Upadacitinib + 26-week CS Taper -> Placebo | 0 | 14 |
| Total, all-cause mortality | 15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib | 0 | 92 |
| Total, all-cause mortality | 15 mg Upadacitinib + 26-week CS Taper -> Placebo | 0 | 35 |
| Total, other adverse events | Placebo + 52-week CS Taper | 90 | 112 |
| Total, other adverse events | 7.5 mg Upadacitinib + 26-week CS Taper | 88 | 107 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
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/NCT03725202
GET https://conductscience.org/api/trials/v1/NCT03725202/results?page=2