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Rheumatoid ArthritisPhase 3RETRONCT02779114

RETRO (REduction of Therapy in RA Patients in Ongoing Remission)

A Phase 3 study testing Reduction group 1 and Reduction group 2 in people with Rheumatoid Arthritis, run by University of Erlangen-Nürnberg Medical School at 12 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase 3, multicenter, randomized, open, prospective, controlled, parallel-group intervention study in 318 patients with Rheumatoid Arthritis. The study is composed of 3 phases: a pre-randomization phase for up to 10 days followed by a 1-year randomized, open three arm treatment phase for each patient… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Reduction group 1 and Reduction group 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
12 sitesGermany
Study dates
Jan 2009to Jun 2018
Phase
Phase 3
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

  • Must understand and voluntarily sign an informed consent form including written consentfor data protection
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must be male or female and aged ≥ 18 years at time of consent
  • Must have a diagnosis of RA according to ACR criteria [26] for at least 12 months
  • Must have a DAS 28 score of less than 2.6 (means: remission) at randomization (documented in at least three subsequent controls for six months; compare figure three in the appendix for details)
  • At screening-visit patients should have been treated without alterations of therapy for at least six months with one of the following therapies: (i) one or more of the following conventional DMARDS (with or without concomitant use of glucocorticoids): Methotrexate, Leflunomide, Ciclosporine A, Sulfasalazine, Azathioprine or Hydroxychloroquine, (ii) a combination of a conventional DMARD (Methotrexate, Leflunomide, Ciclosporine A, Sulfasalazine, Azathioprine or Hydroxychloroquine) with one of the following biologicals (with or without concomitant use of glucocorticoids): Infliximab, Adalimumab, Etanercept, Tocilizumab, Golimumab, Certolizumab, Abatacept, (iii) or one of the biologicals mentioned above without combination with a conventional DMARD. All of the aforementioned biologicals are also allowed in combination with glucocorticoids, (iv) monotherapy treatment with glucocorticoids (without any DMARD or biological treatment).

Who cannot join

  • Treatment with Rituximab during the last 12 months before screening
  • Intake of a daily dosage of more than 5mg Prednisolone - equivalent during the last 6 months before randomization; intraarticular injections of glucocorticoids do not represent an exclusion criteria
  • Current treatment with other DMARDS (for example MMF or preparations still in development) than mentioned above
  • Any anti-inflammatory or immunosuppressive therapy for other reasons than RA during the last 3 months before screening
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Any other rheumatological/immunological disease such as Psoriasis, Psoriatic Arthritis, SLE, PSS, MCTD, M. Bechterew, M. Behcet or M. Wegener. Should the respective diagnosis be confirmed after inclusion into the study the patient will leave the study and data is recorded via "unscheduled visit"- and follow-up form
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  • Florid autoimmune conditions such as autoimmune hepatitis or Hashimoto's disease while still under treatment
  • Patients with a florid malignancy
  • Participation in another phase 1-4 treatment study for RA
  • Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG)
  • Pregnant or lactating female
  • Females of childbearing potential (FCBP is a sexually mature female who 1. has not undergone a hysterectomy or bilateral oophorectomy, or 2. has not been postmenopausal for at least 24 consecutive months) have to use adequate forms of contraception with respect to standard treatment recommendations. However if there is suspicion of a pregnancy in spite of standard treatment recommendations a urine pregnancy test is to be carried out by the Investigator
  • Also males must also use adequate forms of contraception
  • Patients who possibly are dependent on the Principal Investigator or investigator

Trial locations and contacts

12 sites in 1 country.

Georg Schett, Prof. Dr. univ. contact

+49-9131-8533418

georg.schett@uk-erlangen.de

Juergen Rech, Dr. med. contact

+49-9131-8543014

juergen.rech@uk-erlangen.de

12 sites in 1 country

Germany12 sites, 12 recruiting

  • Asklepios Klinikum Bad Abbach

    Bad Abbach

    Martin Fleck, Prof. Dr. med.

    Recruiting

  • Rheumapraxis Manger

    Bamberg

    Karin Manger, Prof. Dr. med.

    Recruiting

  • Rheumapraxis Bayreuth

    Bayreuth

    Wolfgang Ochs, Dr. med.

    Matthias Schmitt-Haendle, Dr. med.

    Recruiting

  • Schlosspark-Klinik

    Berlin

    Rieke Alten, Dr. med.

    Recruiting

  • Schwerpunktpraxis für Rheumatologie Burghausen

    Burghausen

    Martin Feuchtenberger, Dr. med.

    Recruiting

  • PGRN.de Praxisgemeinschaft Rheumatologie Nephrologie

    Erlangen

    Joerg Wendler, Dr. med.

    Florian Schuch, Dr. med.

    Recruiting

  • Universitätsklinikum Heidelberg; Medizinische Klinik V

    Heidelberg

    Hanns-Martin Lorenz, Prof. Dr. med.

    Recruiting

  • Gemeinschaftspraxis Dres. Demary und von Hinüber

    Hildesheim

    Winfried Demary, Dr. med.

    Recruiting

  • Praxiszentrum St. Bonifatius

    München

    Klaus Krüger, Prof. Dr. med.

    Recruiting

  • Praxis Professor Nüsslein

    Nuremberg

    Hubert Nüsslein, Prof. Dr. med.

    Recruiting

  • Universitätsklinikum Tübingen; Zentrum für Interdisziplinäre Klinische Immunologie, Rheumatologie und Autoimmunerkrankungen - INDIRA

    Tübingen

    Joerg Henes, Dr. med.

    Recruiting

  • Medizinische Klinik 2 und Poliklinik, Universitätsklinikum Würzburg

    Würzburg

    Hans-Peter Tony, Prof.Dr.med.

    Marc Schmalzing, Dr. med.

    Recruiting

Other trials in Germany

About this study

Official title: A Phase 3, Multicenter, Randomized, Open, Prospective, Controlled, Parallel Group Study of Reduction of Therapy in Patients With Rheumatoid Arthritis in Ongoing Remission.

This is a phase 3, multicenter, randomized, open, prospective, controlled, parallel-group intervention study in 318 patients with Rheumatoid Arthritis. The study is composed of 3 phases: a pre-randomization phase for up to 10 days followed by a 1-year randomized, open three arm treatment phase for each patient, followed by a 5-year observational phase for all patients still in remission.

Read the detailed description

Rheumatoid Arthritis (RA) is characterized by progressive synovitis leading to degradation of articular cartilage leading to erosions in juxtaarticular bones driven by auto antibodies. Few clinical studies could show that quick and thorough control of inflammatory processes could stop degradation processes [17, 18, 19, 20, 21] and had presumably better prognosis of remission than untreated and/or uncontrolled RA disease [20]. These studies aimed at low disease activity [20], often focused on early RA [18, 19], evaluating different therapy strategies, mostly escalating instead of deescalating medications [20, 21]. Real "RA- in - remission" or therapy reduction studies are missing up to now, even if first small trials focusing on one preparation showed promising results [16, 17].

In this study all conventional medications in usual combinations are being evaluated for the treatment of Rheumatoid Arthritis in different stages of disease duration. The study is scheduled as a 365-day (12-months), phase 3 multicenter, randomized, open, prospective, controlled, parallel-group intervention study in 318 patients with Rheumatoid Arthritis.

Based on the results of the clinical studies mentioned above, and the need for a guideline with therapy proposals for RA- patients in remission all current preparations will be evaluated in subjects under the controlled setting of a clinical study. The information obtained from this study will assess the formulation of new guidelines regarding patients with Rheumatoid Arthritis in remission.

Being tested
Control group, Reduction group 1, Reduction group 2
Keywords
Rheumatoid Arthritis, Remission, Dose reduction
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupDrug

    Stable dosage of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®)

  • Reduction group 1Other

    Dose reduction of 50% for 12 months of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®)

  • Reduction group 2Other

    Dose reduction of 50% of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®) for 6 months and if they are still in remission therapy will be discontinued.

Study groups in NCT02779114
Study groupRoleWhat they receive
Control groupOtherAfter 1:1:1 randomization patients in the control group receive their previous disease modifying therapy of conventional DMARD, biologicals and glucocorticoids during 12 months of the study.
Receives: Drug: Control group; Other: Reduction group 1; Other: Reduction group 2
Reduction group 1OtherPatients in reduction group 1 receive exactly 50% of their previous disease modifying therapy of conventional DMARD, biologicals and glucocorticoids during the first six months of the study.
Receives: Drug: Control group; Other: Reduction group 1; Other: Reduction group 2
Reduction group 2OtherPatients in reduction group 2 receive exactly 50% of their previous disease modifying therapy of conventional DMARD, biologicals and glucocorticoids during the first six months of the study. If they are still in remission they will discontinue their previous disease modifying therapy of conventional DMARD, biologicals and glucocorticoids during the first six months of the study.
Receives: Drug: Control group; Other: Reduction group 1; Other: Reduction group 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects in each treatment group who are still in remission after 12 months (remission defined as DAS 28 < 2.6) reduction or even discontinuation in RA-patients after achievement of long lasting remission.

    Measured: 12 months

Secondary outcomes (19)

  1. Proportion of subjects in each treatment group who are still in remission after 3, 6, 9 months (remission defined as DAS 28 < 2.6).

    Measured: 12 months

  2. Proportion of subjects in each treatment group who are still in remission after 3, 6, 9 months (remission defined according to Pinals - criteria)

    Measured: 12months

  3. Proportion of subjects in each treatment group with increased disease activity

    Measured: 12 months

  4. Proportion of adverse events (to be documented via "unscheduled visit"-sheet)

    Measured: 12 months

  5. DAS 28 after 3, 6, 9 and 12 months

    Measured: 12 months

  6. CRP after 3, 6, 9 and 12 months

    Measured: 12 months

  7. ESR after 3, 6, 9 and 12 months

    Measured: 12 months

  8. Swollen joint counts after 3, 6, 9 and 12 months

    Measured: 12 months

  9. Tender joint counts after 3, 6, 9 and 12 months

    Measured: 12 months

  10. Patient self assessment of pain (VAS) after 3, 6, 9 and 12 months

    Measured: 12 months

  11. Physician's and patient's assessment of global disease activity (VAS) after 3, 6, 9 and 12 months

    Measured: 12 months

  12. Duration of joint stiffness after 3, 6, 9 and 12 months

    Measured: 12 months

  13. HAQ (Health Assessment Questionnaire) after 3, 6, 9 and 12 months

    Measured: 12 months

  14. SF-36 (Short Form) Score after 3, 6, 9 and 12 months

    Measured: 12 months

  15. Coping-Questionnaire after 3, 6, 9 and 12 months

    Measured: 12 months

  16. PASS (patient acceptable symptom state) after 3, 6, 9 and 12 months

    Measured: 12 months

  17. WPAI:RA (Work Productivity and Activity Impairment Questionnaire) after 3, 6, 9, 12 months

    Measured: 12 months

  18. BDI - II (Beck-Depression Inventory) after 3, 6, 9 and 12 months

    Measured: 12 months

  19. Flare Questionnaire RA (German version): At time of potential flare

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2017 (estimated)
  4. Study completionJun 2018 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
318 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779114
Sponsor's protocol ID
UKER00109STUM3
Acronym
RETRO
Status last verified
May 2016
First submitted
16 May 2016
Last updated
23 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Tascilar K, Hagen M, Kleyer A, Simon D, Reiser M, Hueber AJ, Manger B, Englbrecht M, Finzel S, Tony HP, Schuch F, Kleinert S, Wendler J, Ronneberger M, Figueiredo CP, Cobra JF, Feuchtenberger M, Fleck M, Manger K, Ochs W, Schmitt-Haendle M, Lorenz HM, Nuesslein H, Alten R, Kruger K, Henes J, Schett G, Rech J. Treatment tapering and stopping in patients with rheumatoid arthritis in stable remission (RETRO): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Rheumatol. 2021 Nov;3(11):e767-e777. doi: 10.1016/S2665-9913(21)00220-4. Epub 2021 Oct 1.

    PubMed 38297524

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Reduction group 1 and Reduction group 2 in people with Rheumatoid Arthritis, run by University of Erlangen-Nürnberg Medical School at 12 sites in Germany.

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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Georg Schett, Prof. Dr. univ. (+49-9131-8533418, georg.schett@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects in each treatment group who are still in remission after 12 months (remission defined as DAS 28 < 2.6) reduction or even discontinuation in RA-patients after achievement of long lasting remission. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02779114, which also lists 1 linked publication.

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 23 May 2016.

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