Reactive ArthritisNCT00621387
Study of Long-Term Antibiotic Treatment in Reactive Arthritis
A study testing ofloxacin and roxithromycin in people with Reactive Arthritis, run by University of Helsinki at 2 sites in Finland.
Trial summary
This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reactive Arthritis
- What is being tested?
- ofloxacin and roxithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesFinland
- Study dates
- Nov 1993to Jun 1998
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute reactive arthritis
- Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
- Age 18 or older
Who cannot join
- Allergy to quinolones or macrolides
- Treatment with systemic corticosteroids within 2 weeks
- Serum creatinine level elevated over the reference limit
- Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
- Current or planned pregnancy, or lack of contraception
- Known HIV positivity
Show all 9Show fewer
- Blood leukocyte count less than 4.0x109/l
- Blood platelet count less than 100x109/l
- Lack of co-operation.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Division of Rheumatology, Department of Medicine
Helsinki, 00029
Peijas Hospital
Vantaa, 01400
About this study
Official title: Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis
This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. The main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, Ritchie index, joint pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.
- Conditions
- Reactive Arthritis
- Being tested
- ofloxacin and roxithromycin, placebo
- Keywords
- reactive arthritis, antibiotics
- Medical subject headings
- Arthritis, Reactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofloxacin and roxithromycinDrug
Also called Tarivid and Surlid
150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
placeboDrug
placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ofloxacin and roxithromycin Receives: Drug: ofloxacin and roxithromycin |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients recovered from arthritis
Measured: 6 months
Secondary outcomes (6)
Swollen joint count
Measured: 6 months
Tender joint count
Measured: 6 months
Ritchie index
Measured: 6 months
Joint pain (visual analogue scale)
Measured: 6 months
Serum C-reactive protein level
Measured: 6 months
Blood erythrocyte sedimentation rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startNov 1993
- Study completionJun 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reactive ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Investigators
- Marjatta Leirisalo-Repo, MD, Principal investigator, Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621387
- Sponsor's protocol ID
- 121-853-93
- Status last verified
- Nov 2007
- First submitted
- 11 Feb 2008
- Last updated
- 22 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis
- ClinicalTrials.gov ID
- NCT00621387
- Acronym / sponsor ID
- 121-853-93
- Conditions
- Reactive Arthritis
- Keywords
- reactive arthritis, antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Nov 1993
- Study completion
- Jun 1998 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. The main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, Ritchie index, joint pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ofloxacin and roxithromycinofloxacin and roxithromycin |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of acute reactive arthritis
- Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
- Age 18 or older
Key exclusion criteria (9 listed)
- Allergy to quinolones or macrolides
- Treatment with systemic corticosteroids within 2 weeks
- Serum creatinine level elevated over the reference limit
- Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
- Current or planned pregnancy, or lack of contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ofloxacin and roxithromycinAlso: Tarivid and Surlid150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months | Drug | 1 |
| placeboplacebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months | Drug | 2 |
Primary outcome
Proportion of patients recovered from arthritis
Time frame: 6 months
6 secondary outcomes
Swollen joint count
Time frame: 6 months
Tender joint count
Time frame: 6 months
Ritchie index
Time frame: 6 months
Joint pain (visual analogue scale)
Time frame: 6 months
Serum C-reactive protein level
Time frame: 6 months
Blood erythrocyte sedimentation rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjatta Leirisalo-Repo, MD principal investigator
Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ofloxacin and roxithromycin in people with Reactive Arthritis, run by University of Helsinki at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients recovered from arthritis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2008.