Trial · NCT00344448
Pilot Study of Raptiva to Treat Sjogren's Syndrome
NCT00344448, Phase 2, Terminated, National Institute of Dental and Craniofacial Research (NIDCR); results first posted 2015-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Raptiva to Treat Sjogren's Syndrome. Trials, record NCT00344448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00344448
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Raptiva to Treat Sjogren's Syndrome
- NCT number
- NCT00344448
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Conditions
- Sjogren's Syndrome
- Interventions
- Raptiva
- First posted
- 2006-06-26
- Last updated
- 2015-12-21
- Results first posted
- 2015-12-21
- Limitations and caveats
- Early termination due to serious adverse event described in psoriasis which led to the withdrawal of the drug from market.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks | 3 months | Patient will be considered a responder if (s)he demonstrates improvement in 2 / 3 disease activity measures without worsening of the third one. 1. Salivary flow: 0.45 ml / 15 min improvement in unstimulated whole salivary flow from baseline value obtained at the study entry. 2. Salivary gland biopsy: at least 2 points improvement in the focus score on MSG biopsy 3. Tear flow: at least 30% improvement in ophthalmic Oxford grading scheme or normalization of the scale as defined by score of 0 or 2mm improvement in Schirmer test as compared with the baseline in either eye. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks | 3 months | participant | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks | Raptiva | 0 | participant | ||
| Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks | Placebo | 1 | participant |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening | STARTED | Raptiva | 6 | |
| Screening | STARTED | Placebo | 4 | |
| Screening | COMPLETED | Raptiva | 6 | |
| Screening | COMPLETED | Placebo | 3 | |
| Screening | NOT COMPLETED | Raptiva | 0 | |
| Screening | NOT COMPLETED | Placebo | 1 | |
| Double Blind, Placebo Controlled | STARTED | Raptiva | 6 | |
| Double Blind, Placebo Controlled | STARTED | Placebo | 3 | |
| Double Blind, Placebo Controlled | COMPLETED | Raptiva | 4 | |
| Double Blind, Placebo Controlled | COMPLETED | Placebo | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events62
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 | Angular cheilitis | Infections and infestations | Raptiva | 0 | 8 | 0 |
| other | Angular cheilitis | Infections and infestations | Placebo | 1 | 3 | 1 |
| other | Corneal scratches | Eye disorders | Raptiva | 2 | 8 | 2 |
| other | Corneal scratches | Eye disorders | Placebo | 1 | 3 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Raptiva | 1 | 8 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 2 | 3 | 5 |
| other | Dysuria | Renal and urinary disorders | Raptiva | 2 | 8 | 2 |
| other | Dysuria | Renal and urinary disorders | Placebo | 0 | 3 | 0 |
| other | Flulikr symptoms | General disorders | Raptiva | 0 | 8 | 0 |
| other | Flulikr symptoms | General disorders | Placebo | 1 | 3 | 1 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Raptiva | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Raptiva | 8 | 8 |
| Total, other adverse events | Placebo | 3 | 3 |
| Total, serious adverse events | Raptiva | 0 | 8 |
| Total, serious adverse events | Placebo | 0 | 3 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Raptiva vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00344448
GET https://conductscience.org/api/trials/v1/NCT00344448/events?page=2