PET based study for early detection of inflammation and effect of treatment in psoriasis

Evaluation of systemic and vascular inflammation by [18F]-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) in patients with moderate to severe psoriasis randomized to different drug regimens

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/08/004842

Enrollment

Registered

2014-08-07

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: null- Patients with moderate to severe psoriasis

Interventions

Intervention1: Methotrexate: Drug methotrexate 0.5mg/kg weight once weekly dose along with folic acid 2.5 mg twice weekly along with pioglitazone or its matching placebo. Pioglitazone 30 mg once a da

Eligibility

Inclusion criteria

Inclusion criteria: PASI >5 Patients on topical or active light therapy

Exclusion criteria

Exclusion criteria: Patients with chronic inflammatory disease like diabetes mellitus, uncontrolled hypertension with SBP 180 mmHg and DBP 95 mmHg, cardiovascular disease and with coagulopathy 2. Patients on any systemic therapy for psoriasis like methotrexate, retinoids or biologics in preceding 6 weeks 3. Patients on tobacco, alcohol use that is 2 drinks per day or intravenous drug use. 4. Participated in a research study in preceding 6 weeks 5. Major surgery within 3 months of imaging 6. Pregnant females 7. Lactating mothers 8. Patient with liver disease 9. Blood glucose level 150 mg/dl 10. Any other inflammatory condition in the body that in the opinion of investigator may jeopardise the validity of the study or put the patients at the greater risk

Design outcomes

Primary

Measure	Time frame
Composite SUV score (skin, blood vessels, liver, joints) after 12 weeks of treatment with methotrexate or placebo in patients with moderate to severe psoriasisTimepoint: Baseline (0 weeks) and 12 weeks	—

Secondary

Measure	Time frame
Composite SUV score after adding pioglitazone to methotrexateTimepoint: Baseline (0 weeks) and 12 weeks;Change in level of CRP and serum homocysteine levelsTimepoint: Baseline (0 weeks) and 12 weeks;Difference from baseline in composite SUV score among treatment groupsTimepoint: Baseline (0 weeks) and 12 weeks;Effect of treatment on the individual components of SUV scoreTimepoint: Baseline (0 weeks) and 12 weeks;SUV in patients with psoriasis versus non psoriatic patientsTimepoint: Baseline in psoriasis patients and historical control	—

Measure

Time frame

Composite SUV score after adding pioglitazone to methotrexateTimepoint: Baseline (0 weeks) and 12 weeks;Change in level of CRP and serum homocysteine levelsTimepoint: Baseline (0 weeks) and 12 weeks;Difference from baseline in composite SUV score among treatment groupsTimepoint: Baseline (0 weeks) and 12 weeks;Effect of treatment on the individual components of SUV scoreTimepoint: Baseline (0 weeks) and 12 weeks;SUV in patients with psoriasis versus non psoriatic patientsTimepoint: Baseline in psoriasis patients and historical control

—

Countries

India

Contacts

Public ContactDr Samir Malhotra

PGIMER, Chandigarh

sharon25sept@yahoo.co.in

Outcome results

None listed

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