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Role of infliximab treatment in improvement of functional status of patients suffering from ankylosing spondylitis.

Effect of infliximab therapy in functional improvement in patients with ankylosing spondylitis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009646
Enrollment
54
Registered
2017-09-05
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: M459- Ankylosing spondylitis of unspecified sites in spine Health Condition 2: null- Patients with clinical symptoms and radiologically confirmed Ankylosing Spodylitis

Interventions

Intervention1: Inj Infliximab with Rehabilitation programme: For Group A patients Screening for infection, serology, routine blood tests to be done and chest Skiagram to be obtained. Vaccination again

Sponsors

IPGMER SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASAS criteria fulfilled AS patients. 2. Disease causing significant functional limitation. 3. Active disease for >= 4weeks 4. BASDAI >= 4 5. Failed adequate NSAIDs trial. 6. Patients giving consent for the study. 7. Patient mentally sound enough to communicate and participate in the study and can understand the parameters well.

Exclusion criteria

Exclusion criteria: 1. Active infection or septicaemia. 2. Documented Hypersensitivity. 3. Pregnancy. 4. Recent history of malignancy. 5. History of TB in recent past. 6. Congestive cardiac failure (NYHA Class III-IV). 7. Patients with Post myocardial infarction, Post stroke, Post mastectomy, prolonged immobilization. 8. The presence of an unstable medical condition or a known uncontrolled systemic disease, including cancer, diabetes, endocrine disease, major depression, schizophrenia.

Design outcomes

Primary

MeasureTime frame
Bath Ankylosing Spondylitis Functional Index (BASFI).Timepoint: At baseline, 2/6/12 weeks after initiation of treatment.

Secondary

MeasureTime frame
VAS score (0 to 10) for back pain.Timepoint: At baseline, 2/6/12 weeks after initiation of treatment.

Countries

India

Contacts

Public ContactAmbar Konar

IPGMER,SSKM Hospital

rpramanik2000@yahoo.com09432594882

Outcome results

None listed

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