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To identify if there are any clinical or immunological markers that can help us predict disease relapse in a patient. This knowledge can help the physicians to decide when to administer the maintenance treatment to prevent clinical relapse.

Clinical and immunological factors predicting relapse in patients with pemphigus treated with rituximab: A prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028675
Enrollment
50
Registered
2020-10-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L102- Pemphigus foliaceous Health Condition 2: L100- Pemphigus vulgaris

Interventions

None listed

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with confirmed pemphigus vulgaris or foliaceus treated with RTX- RA protocol.

Exclusion criteria

Exclusion criteria: 1. Patients who have received RTX cycles in the preceding one year. 2. Patients with other concomitant autoimmune diseases. 3. Pregnant and lactating patients. 4. Patients who cannot come for follow up visits for at least 18 months.

Design outcomes

Primary

MeasureTime frame
1. Comparison of the changing trends of anti-dsg1, anti-dsg3, and anti-AchR (M3) antibody values between patients who relapse and who do not relapse. 2. Comparison of changing trends of CD 19+ and CD19+27+ B cells between relapsing and non-relapsing patients. 3. Comparison of baseline clinical parameters between relapsing and non-relapsing during the first two years after the initial cycle of rituximab. Timepoint: Baseline, 3, 6, 9, 12 months

Secondary

MeasureTime frame
1. Comparison of baseline immunological and clinical parameters between patients who experience disease flare and those who do not at the end of first month. Timepoint: Baseline, 4 weeks

Countries

India

Contacts

Public ContactDr Sindhuja

All India Institute of Medical Sciences

doctor.vishalgupta@gmail.com011-26594985

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026