---
title: Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population
nct_id: NCT01782469
overall_status: TERMINATED
sponsor: AbbVie (prior sponsor, Abbott)
study_type: OBSERVATIONAL
primary_condition: Rheumatoid Arthritis
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01782469.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01782469"
ct_last_update_post_date: 2015-07-30
last_seen_at: "2026-05-12T06:19:34.184Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

**Official Title:** A Prospective, Multi-center Study in Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

**NCT ID:** [NCT01782469](https://clinicaltrials.gov/study/NCT01782469)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Study stopped due to low enrollment
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 16
- **Lead Sponsor:** AbbVie (prior sponsor, Abbott)
- **Conditions:** Rheumatoid Arthritis
- **Start Date:** 2012-10
- **Completion Date:** 2014-07
- **CT.gov Last Update:** 2015-07-30

## Brief Summary

This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-TNF) therapy in the past.

## Detailed Description

This study was a prospective, observational, single arm, multicenter study. Participants were treated with adalimumab in accordance with usual clinical care practices and local marketing authorization requirements. A total of 5 visits were planned: Baseline (Visit 1), Visits 2, 3, 4 and 5 (Week 13). The time interval between the baseline visit and the second visit was approximately 2-3 weeks, with a window of one week. Additional study objectives were to investigate the rate of RA progression via changes in the B-mode ultrasonography assessment score over time as well as changes in the number of joints with erosion over time. The study was terminated due to low enrollment.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

A patient will be enrolled in this study if he/she fulfills ALL of the following criteria:

* Male or Female patients ≥ 18 years of age with diagnosis of RA
* Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines
* Patient is naïve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study
* Patient has no history of inflammatory arthritis other than rheumatoid arthritis
* Patient has no history of lymphoma or leukemia or other malignancies
* Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion Criteria:

* Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria
* Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression
* Susceptibility to infections including TB, as judged by the investigator
* Patient is carrier of Hepatitis B virus
* Patient is a pregnant or lactating female at the time of screening
```

## Arms

- **Rheumatoid Arthritis (RA) participants** — Male or female participants at least 18 years of age with diagnosis of RA

## Primary Outcomes

- **Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.** _(time frame: Baseline (Visit 1) to 13 weeks)_ — Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.

## Secondary Outcomes

- **Mean Percent Reduction in Ultrasonography Assessment Score** _(time frame: Baseline (Visit 1) to 13 weeks)_
- **Mean Number of Joints With Detected Erosions** _(time frame: Baseline (Visit 1) to 13 weeks)_
- **Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)** _(time frame: Baseline (Visit 1) to 13 weeks)_
- **Mean Change in Health Assessment Questionnaire (HAQ) Score** _(time frame: Baseline (Visit 1) to 13 weeks)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01782469.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01782469*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*