comparison of the effect of Adalimumab and Infleximab in patients with Ankylosing Spondilitis presenting to Alzahra hospital

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200412047047N1

Enrollment

Registered

2020-05-19

Start date

2020-05-21

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

Ankylosing Spondylitis. Ankylosing spondylitis

Interventions

Intervention 1: Intervention group: Patients in group A will be treated with adalimumab once every 2 weeks after first visit at a dose of 40 mg per kilogram.Adalimumab under the brand name Cinnora, ow

by the patients themselves. Intervention 2: Intervention group: Patients in group B will be treated with infliximab at a loading dose of 5 mg per kilogram in week 0-2-6 after first visit and then eve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with known AS according to the American College of Rheumatology not responded to at least 3 months of treatment with 2 different NSAIDs candidates for initiating biological drugs.

Exclusion criteria

Exclusion criteria: having contraindications to receiving anti-TNF drugs including active infection or being at high risk for infection past medical history of cancer past medical history of systemic lupus erythmatosis, past medical history of multiple sclerosis past medical history of an autoimmune disease.

Design outcomes

Primary

Measure	Time frame
BASDAI score. Timepoint: Basic visit, 2 months and 4 months after starting biological drug. Method of measurement: Questionnaire filled by a rheumatologist.	—

Secondary

Measure	Time frame
Schober test. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: measured by a rheumatologist by a meter.;CRP level. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: laboratory.;ESR. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: laboratory.;Enthesitis. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: examination by a rheumatologist.;Occiput-wall distance. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: examination by a rheumatologist using a meter.	—

Measure

Time frame

Schober test. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: measured by a rheumatologist by a meter.;CRP level. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: laboratory.;ESR. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: laboratory.;Enthesitis. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: examination by a rheumatologist.;Occiput-wall distance. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: examination by a rheumatologist using a meter.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarjan Golshani

Esfahan University of Medical Sciences

golshani@med.mui.ac.ir+98 31 3261 8928

Outcome results

None listed

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