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NCT04115397: PREVENT RA
Towards Efficient Prediction and Prevention of Rheumatoid Arthritis
Phase 4 trial testing Zoledronic Acid in Seropositive Muskuloskeletal Complaints in 80 participants. Status unknown.
1 December 2021
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 January 2020 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 December 2022 |
Drugs / interventions tested
- Zoledronic Acid (ZOLEDRONIC ACID) — full drug profile →
- Placebo
Conditions studied
- Seropositive Muskuloskeletal Complaints — all drugs for Seropositive Muskuloskeletal Complaints →
Sponsor
Karolinska Institutet
Who can join
18 and older, any sex, with Seropositive Muskuloskeletal Complaints. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
VAS pain
Time frame: 3 months
PAin on a visual analogue scale
Sponsor's own description
Seropositive Rheumatoid arthritis (RA) is characterized by autoantibodies that develop prior to clinical onset, allowing identification of individuals at risk for disease development. In a unique program in Stockholm, seropositive individuals presenting with musculoskeletal complains are currently identified and followed-up in a dedicated outpatient clinical program. Despite significant disease burden and increased sick leave among these individuals, we lack today any therapeutic and preventive measures. We aim to (1). establish a nation-wide health program, (2). develop an algorithm for disease risk estimation and (3). test a novel strategy to delay and/or prevent disease onset in seropositive at risk individuals with musculoskeletal complains. We will perform a multicentre randomised study to treat autoantibody-positive individuals at risk for developing RA presenting with pain (Population), by repurposing of bisphosphonates (Intervention) as compared to placebo (Control) to treat pain (primary Outcome) and delay/prevent RA development during 1-year follow-up (secondary Outcome)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
An up-to-date overview of computational polypharmacology in modern drug discovery.
Chaudhari R, Fong LW, Tan Z, Huang B, et al · · 2020 · cited 46× · PMID 32452701 · DOI 10.1080/17460441.2020.1767063
Verify or expand the search:
- PubMed search for NCT04115397
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04115397 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 3 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04115397.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing