Trial · NCT03511625
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
NCT03511625, Phase 3, Unknown, Attune Health Research, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis. Trials, record NCT03511625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03511625
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
- NCT number
- NCT03511625
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 6 participants, estimated
- Lead sponsor
- Attune Health Research, Inc.
- Conditions
- Rheumatoid Arthritis
- Interventions
- Acthar Injectable Product, Depo medrol
- First posted
- 2018-04-30
- Last updated
- 2024-01-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment | Samples collected about 30 minutes before first treatment injection and about five days after this first injection | Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear. |
| Primary | Initial degree of inflammation, as measured by a pathologist during histological assessment | Samples collected about five days after first injection of treatment | Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear. |
| Secondary | Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score) | Assessments are performed about 1 hour before first treatment injection | In DAS28, a clinician assesses 28 specified joints for tenderness and swelling. A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h). The patient global health assessment (from 0=best to 100=worst) is also used. A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm. |
| Secondary | Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score) | Assessments are performed about 5 days after first treatment injection | In DAS28, a clinician assesses 28 specified joints for tenderness and swelling. A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h). The patient global health assessment (from 0=best to 100=worst) is also used. A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm. |
| Secondary | Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score) | Assessments are performed about 5-6 weeks after first treatment injection. | In DAS28, a clinician assesses 28 specified joints for tenderness and swelling. A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h). The patient global health assessment (from 0=best to 100=worst) is also used. A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm. |
| Secondary | Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints | Assessments are performed about 1 hour before first treatment injection | A clinician assesses 28 specified joints for tenderness and swelling. |
| Secondary | Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints | Assessments are performed about 5 days after first treatment injection | A clinician assesses 28 specified joints for tenderness and swelling. |
| Secondary | Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints | Assessments are performed about 5-6 weeks after first treatment injection. | A clinician assesses 28 specified joints for tenderness and swelling. |
| Secondary | Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) | Assessments are performed about 1 hour before first treatment injection | The Westergren method requires collecting 2 ml of venous blood into a tube containing 0 .5 ml of sodium citrate. It should be stored no longer than 2 hours at room temperature or 6 hours at 4 °C. The blood is drawn into a Westergren-Katz tube to the 200 mm mark. The tube is placed in a rack in a strictly vertical position for 1 hour at room temperature, at which time the distance from the lowest point of the surface meniscus to the upper limit of the red cell sediment is measured. The distance of fall of erythrocytes, expressed as millimeters in 1 hour, is the Erythrocyte Sedimentation Rate. |
| Secondary | Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after short-term treatment | Assessments are performed about 5 days after first treatment injection | The Westergren method requires collecting 2 ml of venous blood into a tube containing 0 .5 ml of sodium citrate. It should be stored no longer than 2 hours at room temperature or 6 hours at 4 °C. The blood is drawn into a Westergren-Katz tube to the 200 mm mark. The tube is placed in a rack in a strictly vertical position for 1 hour at room temperature, at which time the distance from the lowest point of the surface meniscus to the upper limit of the red cell sediment is measured. The distance of fall of erythrocytes, expressed as millimeters in 1 hour, is the Erythrocyte Sedimentation Rate. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03511625
GET https://conductscience.org/api/trials/v1/NCT03511625/registered