Trial · NCT02030028
ACTH Gel Therapy in Rheumatoid Arthritis
NCT02030028, Not applicable, Completed, Dana Ascherman; results first posted 2023-09-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ACTH Gel Therapy in Rheumatoid Arthritis. Trials, record NCT02030028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02030028
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ACTH Gel Therapy in Rheumatoid Arthritis
- NCT number
- NCT02030028
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 18 participants, actual
- Lead sponsor
- Dana Ascherman
- Conditions
- Rheumatoid Arthritis
- Interventions
- ACTHAR gel
- First posted
- 2014-01-08
- Last updated
- 2023-09-06
- Results first posted
- 2023-09-06
- Limitations and caveats
- This trial was limited by small sample size and reduced number of participants completing the study. Statistical analysis was compromised by missing standard-of-care laboratory values.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 | 12 weeks | percentage of participants achieving \>20% improvement in CDAI after 12 weeks of therapy (\>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 \< 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity) |
| Secondary | Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12 | 12 weeks | Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement. Scale: 0-8.61 (lower scores indicate reduced disease activity) |
| Secondary | Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12 | 12 weeks | Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP \< 0)) |
| Secondary | Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12 | 12 weeks | Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS \< 0) |
| Secondary | Patient Reported Changes in Fatigue Between Week 0 and Week 12 | 12 weeks | The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 | 12 weeks | Study completers (9/13 had evaluable data at baseline and week 12) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12 | 12 weeks | Study completers--5/13 with evaluable data | units on a scale | MEAN |
| SECONDARY | Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12 | 12 weeks | Study completers--7/13 with evaluable data | mg/dl | MEAN |
| SECONDARY | Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12 | 12 weeks | Study completers--8/13 with evaluable data | mm/hr | MEAN |
| SECONDARY | Patient Reported Changes in Fatigue Between Week 0 and Week 12 | 12 weeks | Study completers--13/13 with evaluable data | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 | ACTHAR Gel | 8 | Participants | ||
| Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12 | ACTHAR Gel | -0.87 | Standard Deviation 1.75 | units on a scale | |
| Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12 | ACTHAR Gel | 0.36 | Standard Deviation 1.33 | mg/dl | |
| Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12 | ACTHAR Gel | -7.38 | Standard Deviation 28.30 | mm/hr | |
| Patient Reported Changes in Fatigue Between Week 0 and Week 12 | ACTHAR Gel | -3.8 | Inter-Quartile Range -23.1 to 5.4 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ACTHAR Gel | 18 | |
| Overall Study | COMPLETED | ACTHAR Gel | 13 | |
| Overall Study | NOT COMPLETED | ACTHAR Gel | 5 |
Source ClinicalTrials.gov
Adverse events1
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 | rib fractures | Musculoskeletal and connective tissue disorders | ACTHAR Gel | 1 | 18 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACTHAR Gel | 0 | 18 |
| Total, other adverse events | ACTHAR Gel | 1 | 18 |
| Total, serious adverse events | ACTHAR Gel | 0 | 18 |
Source ClinicalTrials.gov
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/NCT02030028
GET https://conductscience.org/api/trials/v1/NCT02030028/registered