Trial · NCT00501995
High Dose Cyclophosphamide for Treatment of Scleroderma
NCT00501995, Phase 3, Completed, Johns Hopkins University; results first posted 2014-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High Dose Cyclophosphamide for Treatment of Scleroderma. Trials, record NCT00501995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00501995
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High Dose Cyclophosphamide for Treatment of Scleroderma
- NCT number
- NCT00501995
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Scleroderma
- Interventions
- IV Cyclophosphamide
- First posted
- 2007-07-17
- Last updated
- 2017-06-14
- Results first posted
- 2014-07-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in the Modified Rodnan Skin Score. | 0 to 24 months | The modified Rodnan skin score is the accepted clinical measure of scleroderma skin activity. The investigator will assess the thickening of the skin using the modified Rodnan skin score through simple palpation on 17 different body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness is assessed on a scale of 0-3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0-51; 0 (normal) to 51 (severe thickening in all 17 areas) A 25% improvement in the modified Rodnan Skin score will be considered significant at any time point in the study. Modified Rodnan Skin Score was evaluated at months 0,1,3,6,12 and 24 months. |
| Secondary | Change in the HAQ-DI, PGA, FVC and DLCO | 0-24 months | The Health Assessment Questionnaire-Disability Index (HAQ-DI) a 48 item questionnaire assessing ability to perform activities of daily living, use of assistive devises and a 6 item analog scale of pain severity from 0 cm (no pain) to 14.3 cm (very severe pain). The lower the HAQ-DI score the less the disability. The physician global assessment (PGA) which is a visual analogue scale from 0 to 100 on which the physician rates the patient's disease severity based on their observations. A score of 0 is no disease activity and 100 is the worst possible disease activity. The Forced Vital Capacity (FVC) measure of lung capacity and Diffusing Capacity (DLCO) measures of oxygen exchange in the alveoli ( pulmonary function testing). The predicted lung volumes were referenced from NHANES/Hanikson et al and for DLCO predicts were from Knudson. Pre and post study percent predicted values were compared. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement in the Modified Rodnan Skin Score. | 0 to 24 months | Patient 4 died during the early phase of the study and longitudinal assessment of his skin score was not determined. | percent improvement from baseline | MEAN |
| SECONDARY | Change in the HAQ-DI, PGA, FVC and DLCO | 0-24 months | The study group consisted of 4 men and 2 women aged 19-60 years of old. | percentage change | MEAN |
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 |
|---|---|---|---|---|---|
| Improvement in the Modified Rodnan Skin Score. | IV Cyclophosphamide (50 mg/kg) | 46.75 | Full Range 31 to 60 | percent improvement from baseline | |
| Change in the HAQ-DI, PGA, FVC and DLCO | IV Cyclophosphamide (50 mg/kg) | HAQ-DI score | 79 | Full Range 0 to 93 | percentage change |
| Change in the HAQ-DI, PGA, FVC and DLCO | IV Cyclophosphamide (50 mg/kg) | PGA | 71 | Full Range 62 to 80 | percentage change |
| Change in the HAQ-DI, PGA, FVC and DLCO | IV Cyclophosphamide (50 mg/kg) | FVC | 0 | Full Range -7 to 5 | percentage change |
| Change in the HAQ-DI, PGA, FVC and DLCO | IV Cyclophosphamide (50 mg/kg) | DLCO | 14 | Full Range 2 to 29 | percentage change |
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 | IV Cyclophosphamide (50 mg/kg) | 6 | |
| Overall Study | COMPLETED | IV Cyclophosphamide (50 mg/kg) | 5 | |
| Overall Study | NOT COMPLETED | IV Cyclophosphamide (50 mg/kg) | 1 |
Source ClinicalTrials.gov
Adverse events16
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 | neutropenic fever | Immune system disorders | IV Cyclophosphamide (50 mg/kg) | 5 | 6 | 5 |
| other | nausea/vomitting | Gastrointestinal disorders | IV Cyclophosphamide (50 mg/kg) | 3 | 6 | 3 |
| other | diarrhea | Gastrointestinal disorders | IV Cyclophosphamide (50 mg/kg) | 3 | 6 | 3 |
| other | oedema | Vascular disorders | IV Cyclophosphamide (50 mg/kg) | 3 | 6 | 3 |
| other | pneumonia | Respiratory, thoracic and mediastinal disorders | IV Cyclophosphamide (50 mg/kg) | 1 | 6 | 1 |
| other | septic bursitis | Musculoskeletal and connective tissue disorders | IV Cyclophosphamide (50 mg/kg) | 1 | 6 | 1 |
| other | rash | Skin and subcutaneous tissue disorders | IV Cyclophosphamide (50 mg/kg) | 2 | 6 | 2 |
| other | sexual dysfunction | Reproductive system and breast disorders | IV Cyclophosphamide (50 mg/kg) | 3 | 6 | 3 |
| other | amenorrhea | Reproductive system and breast disorders | IV Cyclophosphamide (50 mg/kg) | 1 | 6 | 1 |
| other | itch | Skin and subcutaneous tissue disorders | IV Cyclophosphamide (50 mg/kg) | 2 | 6 | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Cyclophosphamide (50 mg/kg) | ||
| Total, other adverse events | IV Cyclophosphamide (50 mg/kg) | 6 | 6 |
| Total, serious adverse events | IV Cyclophosphamide (50 mg/kg) | 1 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17974598 | RESULT |
Source PubMed
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/NCT00501995
GET https://conductscience.org/api/trials/v1/NCT00501995/registered