Trial Outcomes & Findings for Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid (NCT NCT00584935)

NCT ID: NCT00584935

Last Updated: 2018-02-07

Results Overview

Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth) 1. 0-25% 2. 25-50% 3. 50-75% 4. 75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by symblepharons and n is the number of symblepharons countable) a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2018-02-07

Participant Flow

Three patients were recruited from the investigator's practice.

Subjects must meet inclusion/exclusion criteria.

Participant milestones

Measure	Rituximab
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid

Baseline characteristics by cohort

Measure	Rituximab n=3 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 28 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: The data for this Outcome was not collected and due to the length of time, the records have been destroyed.

Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth)

1. 0-25%

2. 25-50%

3. 50-75%

4. 75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by symblepharons and n is the number of symblepharons countable)

a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 weeks

Population: The data for this Outcome was not collected and due to the length of time, the records have been destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Population: The data for this Outcome was not collected and due to the length of time, the records have been destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: The data for this Outcome was not collected and due to the length of time, the records have been destroyed.

Outcome measures

Outcome data not reported

Adverse Events

Rituximab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wendy Cantrell, CRNP

UAB Department of Dermatology

Phone: 205-502-9960

Email: wcantrell@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator is required to submit the final manuscript to the sponsor prior to publication. The sponsor may suggest changes but investigator retains editorial rights.
• Publication restrictions are in place

Restriction type: OTHER